Illustration
Omnilux
Clear
FDA cleared · K210948
“Cleared” means the FDA found the device substantially equivalent to one already legally sold, for a stated use. It isn’t proof it works for you. What clearance means
What it’s cleared for
The Omnilux CLEAR acne facemask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris on the face.
From the FDA filing (K210948, page 6) — verbatim — not yet human-reviewed · retrieved 2026-10-19
Who should skip it
- Skip light devices if you have a light-sensitive condition such as lupus. Source: American Academy of Dermatology: is red light therapy right for your skin?
Safety notes
- Wear eye protection if the directions tell you to, using the eye protection that's recommended. Source: American Academy of Dermatology: is red light therapy right for your skin?
The FDA record
Yes — the FDA record names Omnilux Clear.
K210948 · View FDA record
- Device name in the FDA record
- Omnilux CLEAR
- Applicant
- Globalmed Technologies
- Decision date
- 2021-06-24
- Product code
- OLP: Over-The-Counter Powered Light Based Laser For Acne
- Evidence
- FDA record names this model; retail model variants are not inferred. openFDA source; retrieved 2026-10-19.
Specifications
- Red wavelength
- 630 ± 5 nm · From FDA filing — not yet human-reviewed · page 8 · retrieved 2026-10-19
- Blue wavelength
- 412.5 ± 7.5 nm · From FDA filing — not yet human-reviewed · page 8 · retrieved 2026-10-19
- Total irradiance
- 44 mW/cm² · From FDA filing — not yet human-reviewed · page 8 · retrieved 2026-10-19
- Blue fluence
- 16.8 J/cm² · From FDA filing — not yet human-reviewed · page 9 · retrieved 2026-10-19
- Red fluence
- 9.6 J/cm² · From FDA filing — not yet human-reviewed · page 9 · retrieved 2026-10-19
- Treatment areas (see source for restrictions)
- face · Source — not yet human-reviewed · retrieved 2026-10-19
- Coded cautions (read full instructions)
- pregnancy, photosensitive · Source — not yet human-reviewed · retrieved 2026-10-19
Manual minimum age is 14, so the under-18 code is not asserted. Photosensitivity and pregnancy warnings are explicit. Oozing/bleeding pustules are also excluded; no broad open-wound mapping invented. - Session minutes (see source for treatment area)
- 10 · Source — not yet human-reviewed · retrieved 2026-10-19
- Warranty (years)
- 2 · Source — not yet human-reviewed · retrieved 2026-10-19
- Return window (days; conditions apply)
- 45 · Source — not yet human-reviewed · retrieved 2026-10-19
From delivery; $15 USD return fee; original box and accessories required.
Technical details appear only after we’ve checked and cited a source.
Price
USD 395 · Source · retrieved 2026-10-20
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Where to buy
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