09 Jun 2026
FDA-Cleared LED Face Masks Compared (2026)
How to read this comparison
"FDA-cleared LED mask" gets used loosely. What actually matters is:
- Cleared indications — what conditions the device is cleared to treat
- Cleared area of use — usually the face (sometimes additional areas)
- Cleared wavelengths — typically 415nm blue, 630nm red, 850nm near-infrared
- Protocol — minutes per session, sessions per week
Below, each device is compared on those four dimensions, plus price.
AWA LX300
- FDA status: 510(k) Class II cleared
- Cleared indications: Treatment of full face wrinkles (red + IR); treatment of mild-to-moderate inflammatory acne (blue or mixed)
- Cleared area: Face
- Cleared wavelengths: 415nm blue, 630nm red, 850nm near-infrared
- Protocol: 10 minutes per session, 3-4 times per week
- Extras (not part of FDA clearance): Ships with a complementary neck piece accessory
- Price: Typically well under $250 on sale
- Returns/warranty: 60-day risk-free trial, 1-year warranty, FSA/HSA eligible
CurrentBody Skin LED Mask Series 2
- FDA status: 510(k) cleared LED face mask
- Cleared indications: Wrinkle reduction (face)
- Cleared area: Face
- Wavelengths: Red + near-infrared
- Protocol: ~10 minutes per session
- Price: ~$470
- Notes: Owned by Beauty Tech Group (UK). Separate dedicated neck/décolleté device sold separately.
Higher Dose Red Light Face Mask V4
- FDA status: Marketed as FDA cleared
- Cleared area: Face
- Wavelengths: 630nm red + 830nm near-infrared
- Protocol: 10 minutes per session
- Price: ~$349
- Notes: Separate dedicated red light neck device sold separately.
TheraFace Mask (Therabody)
- FDA status: 510(k) cleared LED face mask
- Cleared area: Face
- Wavelengths: Red, red+infrared, blue
- Price: ~$649.99
- Notes: Face-only design.
Omnilux Contour Face
- FDA status: 510(k) cleared LED face mask
- Cleared indications: Wrinkle reduction (face)
- Wavelengths: Red 633nm + near-infrared 830nm
- Protocol: 10 minutes per session
- Price: ~$395
- Notes: Separate Omnilux Contour Neck and Contour Décolleté sold separately at $295 each.
Side-by-side
| Device | Cleared for | Area | Includes neck piece | Price |
|---|---|---|---|---|
| AWA LX300 | Wrinkles + acne | Face | Yes (complementary accessory) | Under $250 |
| CurrentBody Series 2 | Wrinkles | Face | No (separate device) | ~$470 |
| Higher Dose V4 | Wrinkles | Face | No (separate device) | ~$349 |
| TheraFace Mask | Wrinkles + acne | Face | No | ~$650 |
| Omnilux Contour | Wrinkles | Face | No (separate device) | ~$395 |
The bottom line
Among FDA 510(k) cleared LED face masks, the AWA LX300 is one of the few that pairs the cleared face mask with a complementary neck piece accessory in the same box — at a price below most competitors' face-only options.
If you only want a face mask: any of these is reasonable. If you want the neck area covered too: the LX300 ships with a neck piece accessory; competitors require buying a second device.
View the AWA LX300 — 60-day trial, 1-year warranty, FSA/HSA eligible.
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