Omnilux Clear review: the acne mask by its FDA file
One mask, $395. The Clear is Omnilux's acne mask, not its wrinkle mask: 415 and 633 nm, 132 LEDs and built-in eye shields, four sessions a week for six weeks. It has been FDA-cleared since 2021 (K210948) "to treat mild to moderate acne vulgaris on the face". For wrinkles, look at the Contour Face instead. $395, checked Oct 7, 2026.
By Kirill Gissa · Published · Prices and FDA checked Oct 7, 2026Omnilux Clear at a glance
Output: "claimed" is Omnilux's figure with no distance stated.
Verdict
The Clear scores 9.5/10 by our method: full marks for FDA record, price and warranty and returns; 1.75 of 2 for published specs (only part of the specs published) and owner reviews (owner reviews not summarized yet). It does one job, and its FDA file names that job and gives the output of each color.
you have mild to moderate acne on the face, you're 14 or older, and you want a mask whose output is spelled out in its FDA paperwork.
you have a darker skin tone and haven't talked to a dermatologist (see below), if a few spots are the whole problem, or if you want one mask for acne and wrinkles at once.
Alternatives for acne
CurrentBody Series 3, $569.99. One mask with several modes; its 510(k) (K260715) names a blue-and-red mode "intended for the treatment of mild to moderate inflammatory acne" next to separate wrinkle and pain modes.
Solawave Bye Acne, $69. A spot device, 415 and 630 nm, 3 min per spot, 3–5 times a week. Its FDA listing points to K203271, a 510(k) for a Shenzhen Kaiyan handheld with no public summary, so its specs can't be checked against the file.
Shark CryoGlow, $299.99. Cheaper, with 415, 630 and 830 nm and under-eye cooling; its 510(k) (K242796) covers both wrinkles and mild to moderate acne. Warranty: 2 years (Limited Warranty); returns: 60-day money-back guarantee.
All masks with their wavelengths: LED masks.
Specs from the 510(k)
Omnilux's product page gives round numbers: blue at 415 nm, red at 633 nm and "an output of 44mw/cm2" (product page, archived Sep 15, 2026). The 510(k) summary for K210948 is more precise:
- Blue: 412.5 nm ± 7.5 nm, 28 mW/cm², 16.8 J/cm² per session.
- Red: 630 nm ± 5 nm, 16 mW/cm², 9.6 J/cm² per session.
The numbers add up: 28 mW/cm² for 600 seconds is 16.8 J/cm², and the 44 on the product page is the two colors combined, mostly blue. For scale, a 2022 review of home devices suggested 6 to 40 mW/cm² for blue and 8 to 80 for red; both of the Clear's figures sit inside those ranges.
Globalmed Technologies filed it, and the FDA decided on Jun 24, 2021 under product code OLP, the acne code. The device it was compared with is a handheld, the "Acne Light Therapy Wand" (K160691). The OMNILUX CLEAR-U (K081307, 2009) that turns up in searches is a different, older device. More cleared masks: FDA-cleared LED masks.
Omnilux Clear vs Contour Face
| Omnilux Clear | Omnilux Contour Face | |
|---|---|---|
| Price | $395 | $395 |
| Wavelengths | 415 and 633 nm | 633 and 830 nm |
| LEDs | 132 | 132 |
| Brand output | 44 mW/cm² (510(k): blue 28 + red 16) | about 30 mW/cm² |
| Session | 10 min, 4 times a week for 6 weeks; brand says no more than 6 weeks in a row | 10 min |
| FDA | Cleared, K210948 (Jun 24, 2021) | Cleared, K191629 (Sep 12, 2019) |
| Warranty | 2 years device, 2 years controller | 2 years device, 1 year controller |
| Returns | 30-day money-back guarantee | 30 days for LED devices |
Same price, same 132 LEDs. The Clear swaps near-infrared for blue and is cleared for acne; the Contour Face is cleared for full-face wrinkles. Omnilux puts the Clear at 14 and up and the Contour at 21 and up, and only the Clear has eye shields built in, because "some people may be overly sensitive to blue light."
Alternating them is out. Omnilux: "these devices should not be used at the same time. We recommend starting off by addressing your blemishes and acne." One oddity: the archived Clear page reads "2 years: device 2 year: controller", while Omnilux's Contour page gives the controller 1 year. Ask before counting on the longer term.
How to use it, and how not to
Omnilux's schedule: "Four 10-minute treatments per week for 6 weeks. Once the initial series is complete, use the device at the earliest signs of a breakout." "You should not use the Clear device for more than 6 weeks consecutively." And on extra sessions: "Can I use Clear more frequently than the recommended 4x per week? No. Clear has not been studied for this application."
That second answer is unusually honest: acne trials ranged from daily sessions to two a week, and none showed that more light works better. General timing and skin prep: how to use red light therapy.
Who should skip it
From Omnilux's FAQ on the archived product page:
- "DO NOT use the Omnilux Clear™ if you are a child under 14 years of age."
- Nothing beyond acne: not for conditions "apart from those listed in the indications for use (mild to moderate acne vulgaris)."
- Accutane: "We do not recommend the use of light therapy devices while on Accutane. If you have stopped taking the medication for at least 5 days, the treatment can be safely administered."
- Darker skin: "people with darker skin tones (types IV, V and VI on the Fitzpatrick Scale) may experience transient pigmentation with blue light therapy".
The skin-tone warning has research behind it. In a 2014 study on volunteers with skin types III and IV, 415 nm light darkened skin with "a clear dose effect", for up to three months, while 630 nm red did not. The Clear's blue is centered at 412.5 nm. The American Academy of Dermatology advises people with darker skin to see a dermatologist before using a home device.
Pregnancy: in search results the Clear page says Omnilux products "have not been studied in pregnant or breastfeeding women"; I couldn't open the live page to confirm. More on red light safety, and our medical disclaimer.
Results: what the studies say about timing
None of these trials used the Clear itself. The strongest signal is for blue and red together. In a 2000 randomized trial of 107 people, daily 15-minute sessions of 415 plus 660 nm light improved inflammatory lesions by 76% on average, beating blue alone at weeks 4 and 8 (not at week 12). A 2025 meta-analysis of 6 trials of home devices (216 people) found inflammatory lesions fell 45.3% more than in control groups, but warned the results "might not be generalizable to other devices currently on the market."
The cautious side: a 2016 Cochrane review of 71 trials found that "high-quality evidence on the use of light therapies for people with acne is lacking", and the American Academy of Dermatology's 2024 acne guideline doesn't list light therapy among its recommendations. Treat the Clear as an add-on to what a dermatologist prescribes, not a replacement.
The trials measured at 4, 8 and 12 weeks; the Clear's course ends at 6. Photograph your skin in the same light before and after. More on photos: before and after; on the evidence: red light therapy benefits.
Questions people ask
What are the differences between Omnilux Contour and Omnilux Clear?
The Clear is blue and red (415 and 633 nm), cleared for acne, ages 14+. The Contour is red and near-infrared (633 and 830 nm), cleared for wrinkles, ages 21+. Same price.
Who should not use Omnilux?
Per Omnilux: children under 14 (for the Clear), people on Accutane or off it for less than 5 days, and anyone with a light-sensitivity disorder or on medication that causes one. Blue light can also leave temporary dark marks on darker skin.
Should I use my Omnilux everyday?
No. The Clear is four times a week for six weeks, and Omnilux says more often hasn't been studied. For its other masks it recommends 3 to 5 sessions a week "as we have not studied the effect of using the device every day."
What is the best mask for clear skin?
For acne, look for blue light near 415 nm and a 510(k) under the acne code. The Clear has both; the others are compared on our masks page.
FDA status by model
FDA 510(k) and registration databases, checked Oct 7, 2026