Draft record: not yet reviewed. Last researched 3 Nov 2026.

Omnilux Clear

A flexible silicone mask with 132 LEDs in 66 dual-chip bulbs emitting blue and red light together, with built-in eye shields and a rechargeable handheld controller running a single 10-minute programme.

Wavelengths
415 / 633 nm
Light output
44 mW/cm² (brand's figure)
Session
10 minutes
Power
Rechargeable handheld controller, wired to the mask; mains power supply (100–240 V, 5 V 1 A output) and country adaptors included
Warranty
24 months

11 of 12 key facts published · measures disclosure, not safety, quality or effectiveness

Overview

Might suit you if…

  • You get breakouts: it includes blue light.
  • You want eye protection: eye shields are built in.
  • You want longer cover: a 2-year warranty.

Might not suit you if…

  • You've been advised to avoid blue light: it has a blue mode, so check you can use red on its own.
  • You want to move around freely: the controller is on a cable.

Worked out from the facts on this page, not a recommendation. Everyone's skin and routine are different.

What stands out

  • Publishes a light-output figure (18 of 24 do), but not how it was measured.
  • Has a published study of this exact mask; 6 of 24 masks here do.
  • Sessions of 10 minutes; across the directory, sessions run from 3 to 30 minutes.
  • 24-month warranty; 19 of 24 masks here offer 24 months or more.
  • 4 magazine and newspaper reviews recorded, 4 of them hands-on tests.

What isn't disclosed

  • How output was measured

11 of 12 key facts published. Measures disclosure, not safety, quality or effectiveness.

Where sources disagree

  • Red: 633nm on the product page, FAQ and in the 2025 study; 630nm ±10nm in the user guide's technical specification.
  • Returns policy: 45-day return window for Omnilux Clear. Product page badge: '30-Day Money Back Guarantee'.
  • Controller/battery: 2 years per warranty policy and product page; 1 year for the lithium battery per the user guide.

3 more, shown next to the facts they affect.

Before you buy

  • Read Omnilux's list of who shouldn't use it (12 warnings), in the Safety section.
  • Returns: 45 days from delivery for Omnilux Clear bought on omniluxled.
  • 12 questions we've asked Omnilux are still unanswered (see Open questions).

Common questions

Answered from this mask's research record and the rest of our directory, with where each answer comes from. Not recommendations.

Is the Omnilux Clear FDA cleared?

Yes. We found 510(k) clearance K210948 in the US FDA's database.

Clearance is a US status. It means the FDA accepted the mask as similar to one already on the market; it isn't UK approval and doesn't show that a mask works.

Independently verified Which masks are FDA cleared →

Is it registered as a medical device in the UK?

Yes. It's on the MHRA's public register of medical devices: 'Omnilux CLEAR', Class IIa red/blue light phototherapy unit, by I-Smart Developments Limited (MHRA ref 28780), registered 4 Mar 2024.

Of the 24 masks in our directory, one is on the register.

Independently verified

How long is a session, and how often should I use it?

Each session lasts 10 minutes.

How often: 4 times per week for 6 weeks, then only at the first signs of a breakout.

Across the 24 masks we list, the typical session is 10 minutes.

Manufacturer-stated

How long does the battery last, and how long does it take to charge?

The rechargeable battery is in the controller. Omnilux doesn't say how many sessions a charge gives.

Omnilux doesn't publish a charge time.

You can't use it while it's charging.

You can't replace the battery yourself, so battery life and the warranty set how long the mask lasts.

Manufacturer-stated

Does it come with eye protection?

Yes. Silicone eye shields are built into the mask.

Manufacturer-stated Eye protection on every mask →

Do I need an app or a subscription?

No. It runs without an app.

Manufacturer-stated

How much does it cost per session?

At the lowest UK price we've checked (£348), used 3 times a week, it works out at £2.23 a session over the first year (£348 ÷ 156 sessions). If it lasts three years, that falls to 74p.

Charging costs less than 0.1p a session at 26.32p per kWh (Ofgem price cap, 1 October to 31 December 2026).

Across the 23 masks with a checked UK price, the typical figure is £1.96 a session over the first year. It's a price comparison, not a measure of value.

Calculated by Luma Index Running costs for every mask →

What light does it use, and does it include blue light?

Omnilux lists blue (415 nm) and red (633 nm).

It uses blue light. Some dermatologists advise caution with blue light on darker skin that marks easily; our wavelengths guide explains why.

Sources disagree. Red: 633nm on the product page, FAQ and in the 2025 study; 630nm ±10nm in the user guide's technical specification.

Manufacturer-stated Wavelengths explained →

How strong is the light?

Omnilux gives 44 mW/cm². It doesn't fully say how this was measured, so figures from different brands may not be comparable.

18 of the 24 masks in our directory publish a light output figure. Across them, published figures run from 6.1 to 143 mW/cm². A higher figure isn't automatically better: dose and session length matter too.

Manufacturer-stated What light output means →

Who shouldn't use it?

Omnilux's warnings on who shouldn't use it, or should check with a doctor first:

  • Children under 14.
  • Pregnancy, trying to conceive or breastfeeding.
  • Light-induced headaches.
  • Genetic conditions of the eyes, or photosensitive disorders of the eye.
  • Lupus erythematosus, photosensitive eczema or albinism.
  • Any photosensitive disorder of the skin.
  • Medication that can cause photosensitivity (e.g. certain antibiotics, chemotherapy drugs, diuretics); brand advises not using while on Accutane (isotretinoin), or until 5 days after stopping.
  • Only for mild to moderate acne vulgaris of the face; not for severe acne, comedonal acne (whiteheads/blackheads only) or clear skin.
  • Do not use on oozing or bleeding pustules.
  • Silicone allergy (mask is medical-grade silicone).
  • Single-person use only; do not share.
  • Remove sunscreen, creams, lotions and make-up before treatment; brand advises against combining with retinol.

Age: 14 and over.

This is the manufacturer's list, not medical advice. If you have a health condition or take medication, ask your GP or pharmacist.

Manufacturer-stated Are LED masks safe? →

Is there a study of this exact mask?

We've found one published study of this exact mask:

  • 30 people. Single-group, open-label before-vs-after study; no control or sham group. Funder or sponsor: GlobalMed Technologies (research funding, per the article's funding statement).

Studies without a comparison group can't separate the mask's effect from other things, such as skincare or the time of year.

Source read by Luma Index (results not verified) Study details →

What do reviewers say about it?

We've logged 4 press reviews, 4 of them hands-on.

Most often praised: cordless and hands-free (4 of 4), testers saw visible results (3 of 4) and good eye protection or open eye area (2 of 4).

Most common complaints: eye area problems (2 of 4), fit or comfort problems (2 of 4) and limited light colours (1 of 4).

These are the publications' views, not ours.

Every review →

What warranty and returns do I get?

Omnilux gives a 2-year warranty.

Sources disagree. Controller/battery: 2 years per warranty policy and product page; 1 year for the lithium battery per the user guide.

If you buy from Omnilux's website, you can return it within 45 days with the original box and accessories, using their prepaid label. A $15 fee is taken off the refund.

Sources disagree. Returns policy: 45-day return window for Omnilux Clear. Product page badge: '30-Day Money Back Guarantee'.

Whatever the warranty says, your rights for a faulty product under the Consumer Rights Act 2015 are against the retailer you bought it from.

Conflicting information Warranty on every mask →

Where do Omnilux's sources disagree?

Sources give different answers on 6 points: wavelengths, returns, warranty, charging port, what it claims and who the manufacturer is. Each one is shown next to the fact it affects, with both sources, so you can check them before you buy.

Conflicting information

Specifications

Light and dose

LightWavelengthLEDs
Blue 415 nm ±10 66
Red 633 nm ±10 66
Total132

Sources differ: Red: 633nm on the product page, FAQ and in the 2025 study; 630nm ±10nm in the user guide's technical specification.

Light output (irradiance)

44 mW/cm²

Maximum output intensity (manual wording). How it was measured isn’t published. Manufacturer-stated

Dose per session

Not published

Not yet checked

Notes on these figures

Manual: 'Maximum Output intensity 44 mW/cm2'. FAQ: 'output of 44mw/cm2'. Whether this is combined blue + red, and the measurement distance, points and instrument, are NOT disclosed.

Light-output figures come from the manufacturer. Independent checks are rare, even in published studies, so treat them as claims. Why

Treatment, power and design

Treatment

Session length
10 minutes
Details

Manual: 'Program time: 10 minutes +/- 11 Seconds'.

How often
4 times per week for 6 weeks, then only at the first signs of a breakout
Details

FAQ: no more than 4 times a week; 'should not use the Clear device for more than 6 weeks consecutively', then a break. Manual: 'DO NOT over treat'. The 2025 study used 4 times a week for 7 weeks.

Modes
Single fixed 10-minute programme (blue + red together); one on/off button
Auto shut-off
Yes, after 10 minutes

Design and power

Controls
Handheld controller on a cable to the mask
Details

Battery-powered controller, so no mains cable during use; the mask's USB-A plug goes into the controller.

Power
Rechargeable handheld controller, wired to the mask; mains power supply (100–240 V, 5 V 1 A output) and country adaptors included

Sources differ: User guide section 3: micro-USB connector to the controller; section 6.1 and product page: USB-C.

Details

Charging connector: user guide section 6.1 and product page say USB-C; the guide's device description (section 3) still says micro-USB. See conflicts. Rated IP22.

Battery
Lithium-ion polymer, in controller; capacity not stated
Details

Manual: controller battery minimum lifetime 1 year; mask minimum lifetime 2 years.

Charge time
— Not disclosed
Details

Not published by Omnilux. The Sun (Jan 2026) lists '5 – 6 hours for at least 10 treatments'; not confirmed by the brand.

Use while charging
No
Details

Manual: 'cannot be operated whilst charging'. QSG: charging with the mask connected 'can cause damage to the device & battery over time'.

Eye protection
Built-in silicone eye shields
Details

Manual: 'Flexible silicone CLEAR device with integrated eye-wear'. FAQ: tested to IEC/EN 62471 and 'deemed safe to use on uncovered eyes', with shields added because 'some people may find that they are sensitive to blue light'.

Weight
— Not disclosed
Details

Not published. T3 (Aug 2023) reports 330 g for mask and controller combined; not confirmed by the brand. The brand's store data lists 1,588 g, which appears to be a shipping weight.

App needed
No
Details

Operated by controller button; no app mentioned.

Subscription
No
Details

No app or paid features mentioned.

Replaceable battery
No
Details

'The Omnilux Clear device contains no serviceable parts.' Manual advises professional battery removal at end of life.

Values are as stated by Omnilux unless marked otherwise.

What Omnilux claims quoted, not verified

“FDA Cleared for the treatment of mild to moderate acne vulgaris on the face.”

“The only flexible, home-use LED mask with FDA, TGA, and CE clearance for treating acne.”

“Reduces active acne and blemishes; Helps clear breakouts faster; Unveils a brighter, more radiant complexion”

“In a clinical study, Omnilux Clear users agreed: Saw a decrease in inflammatory acne 93%; Would likely recommend the Omnilux Clear device 83%; Would likely choose Omnilux Clear over a topical acne treatment 79%”

Context

Shown beside the Ablon 2025 citation. The abstract reports 86% achieving a ≥1-grade IGA improvement; the 93/83/79% figures were not checked against the full paper.

“The Clear device uses blue and red light emitting diodes (LEDs) to eliminate bacteria on the surface of the skin to neutralize acne flare ups.”

“Data also suggests that blue and red light therapy helps prevent future breakouts.”

Context

The user guide says Clear 'should NOT be used to prevent pimples or spots forming'.

“Omnilux Clear may help to reduce the chances of scarring and may soften the appearance of acne scarring.”

“Omnilux Clear generates no heat or UV light.”

Evidence

Studied: This exact mask

Single-group, open-label before-vs-after study; no control or sham group · 30 participants

What it measured and its limits

Measured: Inflammatory and non-inflammatory lesion counts (each reported as significantly reduced, p<0.0001); 86% achieved ≥1-grade IGA improvement; quality-of-life and tolerability questionnaires. Few adverse events, reported as mild and transient

  • No control group (open-label; the author names this as the main limitation)
  • Small sample (30)
  • Funded by the brand's operator; the author declares no conflicts, but the brand site has a product-launch page naming Dr Glynis Ablon
  • Abstract only read; lesion-count changes and completion numbers not checked

General research on red light doesn't prove a particular mask gives the same results. Research overview

What reviewers say

Summaries in our own words. Luma Index hasn't tested this mask.

Showing 3 of 4: hands-on UK tests first, then the most recent.

The Sun

UK · 10 Feb 2026 · tested

Best LED mask for hyperpigmentation

  • Tester saw blemishes calm quickly and clear faster over time
  • Blue and red light
  • Could still read or watch TV once used to the brightness
  • Eye openings were uncomfortable and left temporary indent lines
About this review

Rated 7/10. Repeats the brand's description of 'the most powerful, medical-grade LED lights available for acne-prone skin'. Lists 132 LEDs (66 bulbs), 415/633 nm and '5 – 6 hours for at least 10 treatments' charging, which Omnilux doesn't publish. Price £348 at Omnilux. Roundup by Sophie Bates and the Sun Shopping team; carries the line 'recommendations… informed by expert editorial opinion' and an affiliate disclosure.

Read the article ↗
T3

UK · 12 Aug 2023 · tested

  • Tester with adult acne saw fewer, milder breakouts and fading marks over six weeks and beyond
  • Switches off after 10 minutes
  • Pocket-sized controller and built-in eye shields let her use screens during sessions
  • Some pressure on the bridge of the nose (eased by loosening the top strap)
  • Pricey
About this review

Single-product review, rated 5/5, by Joanna Ebsworth. The tester notes she also made diet and supplement changes on a nutritionist's advice at the same time. Repeats brand claims ('100% natural', 'no downtime or side effects', up to 72% of acne cleared in four weeks); the user guide lists side effects. Says she found the glow warm (Omnilux: no heat). Reports 330 g for mask and controller combined, not published by Omnilux; says 64 bulbs in one place and 66 in another. Gives £348 RRP and a 45-day money-back guarantee. Older review (2023). Article carries an affiliate disclosure.

Read the article ↗
Women's Health UK

UK · 30 Oct 2026 · tested

Best LED mask for breakouts

  • Built-in eye shields and flexible fit
  • Tester with adult acne saw a visible difference
  • Pocket controller lets you move around during sessions
  • No near-infrared light
  • Some testers found the eye shields dug into their skin
About this review

Calls the controller a 'remote control'; it is a handheld controller on a cable. Calls it FDA-cleared (K210948). Price £348 at Omnilux. Tested by WH Nutrition Editor Alice Barraclough, who says it was recommended to her by a facialist. Article carries an affiliate disclosure.

Read the article ↗
Show all 4 reviews
Shape (US)

US · 24 Jun 2026 · tested

Best for acne

  • Flexible, hands-free mask with 10-minute sessions
About this review

Page returned 402 to us; based on notes in research/candidates.csv only, not re-read. Tester Summer Cartwright used it after a course of Accutane (Omnilux advises waiting at least 5 days after stopping). Price quoted $395. Show with a US flag.

Read the article ↗

Safety and regulation

Who shouldn't use it Omnilux's list

  • Children under 14
  • Pregnancy, trying to conceive or breastfeeding
  • Light-induced headaches
  • Genetic conditions of the eyes, or photosensitive disorders of the eye
  • Lupus erythematosus, photosensitive eczema or albinism
  • Any photosensitive disorder of the skin
  • Medication that can cause photosensitivity (e.g. certain antibiotics, chemotherapy drugs, diuretics); brand advises not using while on Accutane (isotretinoin), or until 5 days after stopping
  • Only for mild to moderate acne vulgaris of the face; not for severe acne, comedonal acne (whiteheads/blackheads only) or clear skin
  • Do not use on oozing or bleeding pustules
  • Silicone allergy (mask is medical-grade silicone)
  • Single-person use only; do not share
  • Remove sunscreen, creams, lotions and make-up before treatment; brand advises against combining with retinol

Age: 14 and over

Regulatory status

UK
MHRA device registration: Registered: 'Omnilux CLEAR', Class IIa red/blue light phototherapy unit, by I-Smart Developments Limited (MHRA ref 28780), registered 4 Mar 2024 Independently verified
Details

From the PARD search recorded on 2 Nov 2026. PARD is a JavaScript app; we could not re-run the search on 3 Nov. Registration is a notification to the MHRA, not an approval or a test of effectiveness. The only Omnilux device found on PARD.

UK
UKCA Not disclosed
Details

No UKCA mark or wording found in the user guide or on the product page; the guide shows CE marking. Page lists 'Certifications: FDA, CE, TGA'.

EU
CE marking: User guide: 'Conforms to Medical Device Regulation (MDR) - 2017/745'; the number 1912 is printed with the marking; EU authorised representative Med-Di-Dia Limited, Galway, Ireland Manufacturer-stated
Details

1912 appears to be a notified body number; not confirmed. Declaration of conformity not published.

US
FDA 510(k) clearance: K210948 (device name 'Omnilux CLEAR', applicant Globalmed Technologies, Napa CA; received 30 Mar 2021, cleared 24 Jun 2021 as substantially equivalent; product code OLP, 'Over-The-Counter Powered Light Based Laser For Acne', 21 CFR 878.4810, Class II) Independently verified
Details

The GUDID record for 'Omnilux CLEAR' (TN2112, DI 05060534510234) cites K210948. Brand says 'FDA Cleared for the treatment of mild to moderate acne vulgaris on the face'; the 510(k) summary (indications, predicate) was not read, as FDA accessdata blocks automated access. An earlier clinic device, 'OMNILUX CLEAR-U' (K081307, 2009, Photo Therapeutics), is a different product. US status only — not a UK approval.

AU
TGA: Product page lists 'TGA'; user guide names Emergo Australia as Australian sponsor Not yet checked
Details

ARTG entry not checked.

Safety standards declared (1)

IEC/EN 62471 (photobiological safety)

Brand FAQ: Clear has been 'tested to conform to medical device standards including IEC/EN 62471'. The user guide gives IP22 and BF applied-part ratings but no list of standards. Test reports not published; IEC 62471 risk group not stated.

A conformity mark or US FDA clearance doesn't prove a device works. "Not published" doesn't mean unsafe. If you have a medical condition, are pregnant or take light-sensitising medicines, ask your GP or pharmacist first.

Ownership and retailers

Ownership

Company
I-Smart Developments Ltd, 129 Green Lanes, Sutton Coldfield, West Midlands, B73 5LT
Warranty
24 months Conflicting information

Sources differ: Controller/battery: 2 years per warranty policy and product page; 1 year for the lithium battery per the user guide.

Details

Device 24 months in all sources. Controller/battery: 2 years per warranty policy (which names Omnilux Clear and 'the included device controller') and product page ('2 year: controller'); user guide: 'The lithium battery is guaranteed for 1 year'. Original purchaser only; brand site or authorised providers. Manual limits implied warranties to one year. UK statutory rights also apply.

Returns
45 days from delivery for Omnilux Clear bought on omniluxled.com; original box and accessories required; $15 USD return fee deducted from refund; returns via brand's prepaid label Conflicting information

Sources differ: Returns policy: 45-day return window for Omnilux Clear. Product page badge: '30-Day Money Back Guarantee'.

Details

Returns policy: 'Omnilux Clear LED device has a 45-day Return Policy' (other LED devices 30 days). Product page badge: '30-Day Money Back Guarantee' (see conflicts). T3 also reports a 45-day money-back guarantee. Policy is written for a US audience (USD fee). Retailer purchases: contact retailer. UK statutory rights also apply.

User manual
Yes
Details

EU user guide (PDF dated 16 Aug 2023; English, German, Spanish, French, Dutch). Names the legal manufacturer (I-Smart Developments, Sutton Coldfield, UK), EU authorised representative and Australian sponsor; contact address is GlobalMed Technologies, Napa, CA. No separate UK guide found. Quick start and contraindication PDFs also published.

In the box

  • Flexible silicone Clear device with built-in protective eye shields
  • Rechargeable battery controller
  • Power supply and plug adaptors
  • USB-C line to USB-A connector
  • Head straps
  • Carry bag
RetailerPriceCheckedLink
Omnilux (UK market) £348 3 Nov 2026 Visit
Healf £348 3 Nov 2026 Visit
Dermacare Direct Check price 3 Nov 2026 Visit

Prices older than 14 days show "Check price". Amazon prices are not stored.

Other places sources disagree

  • FAQ says blue and red light 'helps prevent future breakouts'; the user guide says Clear 'should NOT be used to prevent pimples or spots forming'.
  • User guide names I-Smart Developments (Sutton Coldfield, UK) as legal manufacturer but says to report incidents to 'the manufacturer Globalmed Technologies'; 510(k) applicant is Globalmed Technologies; GUDID labeler and MHRA registrant are I-Smart Developments Limited.

Open questions (12)

Facts we still need from Omnilux
  • Is the UK unit identical to the EU unit described in the 2023 user guide (TN2112)? Is there a UK-specific guide or UKCA marking?
  • Who is the UK Responsible Person / UK contact for the MHRA-registered device, and what does the UK labelling say?
  • Confirm the CE notified body (is 1912 the notified body number?) and publish the declaration of conformity
  • Irradiance measurement method for the 44 mW/cm² maximum: distance, points, instrument; blue vs red split
  • Reconcile red wavelength (633 vs 630 nm)
  • Controller/battery warranty for UK buyers: 1 or 2 years?
  • Returns for UK buyers: 30 or 45 days, and is the $15 return fee charged?
  • Full text of Ablon 2025: completers, lesion-count changes, adverse events, and the source of the 93/83/79% figures
  • Read the 510(k) K210948 summary: indications for use and predicate device
  • Charge time, sessions per charge, battery capacity; weight of mask and controller
  • IEC 62471 risk group; full list of standards declared
  • Authorised UK retailers list (is Healf authorised?)

Sources (14)

Everything this page is based on
  1. Omnilux Clear (product page incl. Help Center FAQ), Omnilux / GlobalMed Technologies. Accessed 2 Nov 2026.
  2. Omnilux Clear User Guide (EU, 2023, 081623), I-Smart Developments / GlobalMed Technologies. Accessed 2 Nov 2026.
  3. Omnilux Clear Quick Start Guide (EU, 2023, 070523), Omnilux. Accessed 2 Nov 2026.
  4. Omnilux CLEAR contraindications (EN, 101322), Omnilux. Accessed 2 Nov 2026.
  5. Warranty Policy (last modified 10/26/2026), GlobalMed Technologies. Accessed 3 Nov 2026.
  6. Returns Policy (last modified 22 Oct 2026), GlobalMed Technologies. Accessed 3 Nov 2026.
  7. Shipping Policy, GlobalMed Technologies. Accessed 3 Nov 2026.
  8. Clinical Bibliography, Omnilux. Accessed 3 Nov 2026.
  9. openFDA GUDID: Omnilux CLEAR (DI 05060534510234), US FDA. Accessed 2 Nov 2026.
  10. openFDA device/510k record K210948, US FDA. Accessed 2 Nov 2026.
  11. MHRA Public Access Registration Database (PARD) search, MHRA. Accessed 2 Nov 2026.
  12. I-SMART DEVELOPMENTS LIMITED (11153428), Companies House. Accessed 3 Nov 2026.
  13. A 7-Week, Open-Label Study Evaluating the Efficacy and Safety of 415-nm/633-nm Phototherapy… (abstract and funding statement), PubMed / PMC (J Clin Aesthet Dermatol). Accessed 3 Nov 2026.
  14. Omnilux Clear — Healf, Healf. Accessed 3 Nov 2026.

Spotted an error? Request a correction. Last researched 3 Nov 2026.

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