Independently researched · Promising
Worth considering
Omnilux Contour Face
7.2/10
FDA check: Not verified for the Omnilux Contour Face name. K191629 clears the faceLITE LED mask by iSMART Marketing.
- Evidence and claim integrity 7.0/10 30%
- Safety and transparency 8.0/10 20%
- Build and specification verification 8.0/10 20%
- Real-life usefulness 7.0/10 15%
- Value and ownership cost 6.0/10 15%
Best label-vs-measured match: 633/830 nm, ~30 mW/cm2 claimed, 25-28 measured by two independent testers; model TN19G tied to K191629 (faceLITE) for full-face wrinkles. Buy direct for warranty.
Checked November 4, 2026. Recheck by May 4, 2027.
- FDA status for this product name: not verified. The 510(k) summary for K191629 on accessdata.fda.gov clears the faceLITE LED mask by iSMART Marketing for full-face wrinkles. That summary does not name the Omnilux Contour Face or model TN19G.
- Clearance K191629 is filed under faceLITE/Ismart; tie to TN19G is via FDA device listing per Dr. Axe review - confirm on FDA GUDID
- Marketing cites an acne study of a different Omnilux device
- Amazon listings are resellers; warranty risk
- Price ~$535 on maker site as of 2026-11-01 (per recoveryroomlab), approx
View the manufacturer page
Independently researched · Promising
Worth considering
HigherDOSE Red Light Face Mask (MK66-L)
6.7/10
FDA check: K241933 clears HIGHERDOSE Red and Infrared Light Mask (MK66-L) for light-based over-the-counter wrinkle reduction. OpenFDA device record, decision date September 27, 2024.
- Evidence and claim integrity 6.0/10 30%
- Safety and transparency 8.0/10 20%
- Build and specification verification 6.0/10 20%
- Real-life usefulness 7.0/10 15%
- Value and ownership cost 7.0/10 15%
630/830 nm; FDA K241933 names this exact model for full-face wrinkles; ~26 mW/cm2 measured (tester) vs 50 advertised. Uncontrolled maker study in women 45-65.
Checked November 4, 2026. Recheck by May 4, 2027.
- Advertised 50 mW/cm2 is ~2x measured
- Weak coverage on lips/chin/jaw per tester
- Own study had no control group
- Wellness marketing (mood, 'works deep') overreaches the cleared use
- List ~$349 (approx, 2026)
View on Amazon
Independently researched · Promising
Promising, with limits
CurrentBody Skin LED Mask Series 2 (MK-90H)
7.0/10
FDA check: K250966 clears CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H). OpenFDA device record, decision date June 25, 2025. Do not transfer this number to Series 1 or Series 3.
- Evidence and claim integrity 6.0/10 30%
- Safety and transparency 8.0/10 20%
- Build and specification verification 8.0/10 20%
- Real-life usefulness 7.0/10 15%
- Value and ownership cost 6.0/10 15%
633/830/1072 nm; K250966 for this model; most openly documented (ISO 17025 lab test per IrradianceLab), but measured 18.5-23 mW/cm2 vs 30 claimed in other tests.
Checked November 4, 2026. Recheck by May 4, 2027.
- Measured output conflicts across testers (18.5 / 21-23 vs 30)
- Company-funded uncontrolled study (-6.36% wrinkles)
- Series 1 and Series 3 (Amazon B0HJD4W4CF) not tied to a verified clearance - do not transfer K250966 to them
- ~$469.99 maker site 2026-11-01, approx
View the manufacturer page
Independently researched · Supported (for androgenetic/female-pattern hair loss, class-level)
Promising, with limits
iRestore Elite (ID-510) hair cap
6.2/10
FDA check: K222081 clears ID-510 iRestore Elite. OpenFDA device record, applicant Freedom Laser Therapy, decision date October 13, 2022.
- Evidence and claim integrity 7.0/10 30%
- Safety and transparency 7.0/10 20%
- Build and specification verification Not verified 20%
- Real-life usefulness 6.0/10 15%
- Value and ownership cost 4.0/10 15%
A dimension above is marked not verified. The total is the one supplied with this research entry, with that dimension left out. Aura did not fill the gap with a number.
Only hair-loss pick: 625/655/680 nm laser+LED; K222081 clears ID-510 iRestore Elite. Aura notes LLLT evidence for female-pattern hair loss in some people.
Checked November 4, 2026. Recheck by May 4, 2027.
- Get new/sudden shedding evaluated first
- '100% success' marketing claim overreaches
- Scalp irradiance not independently verified
- Expensive (~$1,799 listed), 3-6 months to judge
View on Amazon
Independently researched · Promising
Worth considering
Dermatologist in-office LED series (e.g., LightStim Professional / Omnilux medical)
6.8/10
FDA check: K150098 clears the LightStim Professional 2-Panel Light, the example named in this pick. It does not clear every office device.
- Evidence and claim integrity 7.0/10 30%
- Safety and transparency 9.0/10 20%
- Build and specification verification Not verified 20%
- Real-life usefulness 5.0/10 15%
- Value and ownership cost 5.0/10 15%
A dimension above is marked not verified. The total is the one supplied with this research entry, with that dimension left out. Aura did not fill the gap with a number.
Non-commission alternative: clinician-supervised, higher-output cleared panels (e.g., LightStim Professional 2-Panel K150098) plus diagnosis of what you're treating.
Checked November 4, 2026. Recheck by May 4, 2027.
- Per-session cost adds up; series pricing varies
- Ask which device/clearance the office uses
Find a dermatologist