HigherDOSE Red Light Face Mask or Omnilux Contour Face: which is better?

Both are FDA 510(k) cleared: HigherDOSE Red Light Face Mask under K241933 (held by Shenzhen Kaiyan Medical Equipment Co., Ltd), Omnilux Contour Face under K191629 (held by Ismart Marketing Svcs, Ltd.). HigherDOSE Red Light Face Mask measured 26 mW/cm² at the skin in the cited spectrometer test. Omnilux Contour Face measured 26.7 mW/cm² at the skin in the cited spectrometer test. Treatment time: HigherDOSE Red Light Face Mask 10 or 20 minutes, chosen on the controller; Omnilux Contour Face 10 minutes, a fixed session. A 510(k) clearance is a safety review, not proof of results.

HigherDOSE Red Light Face Mask vs Omnilux Contour Face

Last reviewed October 2026.

Short answer: both masks hold an FDA 510(k) clearance we matched in the FDA database — the HigherDOSE Red Light Face Mask (FDA 510(k) K241933 (2024), held by Shenzhen Kaiyan Medical Equipment Co., Ltd (an OEM/licensor, not the brand on the box)) and the Omnilux Contour Face (FDA 510(k) K191629 (2019), held by Ismart Marketing Svcs, Ltd. (an OEM/licensor, not the brand on the box)). Both were metered under the same cited protocol: the Omnilux Contour Face delivered 26.7 mW/cm² at the skin and the HigherDOSE Red Light Face Mask 26 mW/cm².

	HigherDOSE Red Light Face Mask	Omnilux Contour Face
FDA status	OEM-held K — Cleared — rides an OEM or licensor's K-number	OEM-held K — Cleared — rides an OEM or licensor's K-number
510(k) · holder · decided	K241933 · Shenzhen Kaiyan Medical Equipment Co., Ltd · decided 2024-09-27 · device name “HIGHERDOSE Red and Infrared Light Mask (MK66-L)”	K191629 · Ismart Marketing Svcs, Ltd. · decided 2019-09-12 · device name “faceLITE”
Cleared for	Wrinkles (OHS)	Wrinkles (OHS)
Measured irradiance	26 mW/cm² (cited spectrometer test, 8 November 2025)	26.7 mW/cm² (cited spectrometer test, 7 September 2025)
Dose per session	15.6 J/cm² — ≈15.6 J/cm² over the default 10-minute session	16 J/cm² — 16 J/cm² over the fixed 10-minute session
Wavelengths	630 + 830 nm	633 + 830 nm
Treatment time	10 or 20 minutes, chosen on the controller	10 minutes, a fixed session
In the box	Red Light Face Mask Controller Power supply and country-specific adaptors USB-C to USB-A connector Head straps Carrying or storage bag User manual Goggles	Flexible silicone face device Rechargeable battery controller Power supply and plug adaptors USB-C to USB-A connector Head straps Carry bag
Where to buy	No Amazon link: the Amazon US listing B09WB6PWCC was sold by FRONT ROW (seller A1J4W8BQO23A27) at our 11 October 2026 read, not by Amazon.com or HigherDOSE's own store.	No Amazon link: every Omnilux Contour Face listing on Amazon US read 'Currently unavailable' (ledmaskscore#26, #29); the brand's own page is linked instead, unpaid. Omnilux ↗ (unpaid link)

How to choose

Same protocol, so the irradiance and dose rows are comparable. A higher irradiance means a shorter session for the same dose; a bigger dose per session means more light per sitting. Neither row says anything about results: a 510(k) is a safety and equivalence review, not a results guarantee. If the numbers are close, choose on treatment time, on what is in the box and on who holds the clearance.

Sources and dates

HigherDOSE Red Light Face Mask: FDA 510(k) record K241933 (read 2 October 2026)
HigherDOSE Red Light Face Mask: Light Therapy Insiders spectrometer review (8 November 2025)
HigherDOSE Red Light Face Mask, treatment time and box contents: higherdose.com, Red Light Face Mask product page (read 11 October 2026)
Omnilux Contour Face: FDA 510(k) record K191629 (read 2 October 2026)
Omnilux Contour Face: Light Therapy Insiders spectrometer review (7 September 2025)
Omnilux Contour Face, treatment time: Light Therapy Insiders, Omnilux Contour review (published 7 September 2025, read 11 October 2026)
Omnilux Contour Face, box contents: omniluxled.com, Omnilux Contour Face product page (read 11 October 2026)
Amazon US availability: Amazon US buy box (#desktop_buybox), full page load, delivery address East Hanover 07936; seller ID from #merchantID and the seller= links.

The single-mask pages go deeper: Is the HigherDOSE Red Light Face Mask FDA cleared? · Is the Omnilux Contour Face FDA cleared? · or see the ranking by measured irradiance and the full clearance record.

LED Mask Score indexes manufacturers' FDA marketing claims against the FDA's own public record — the 510(k) database and the registration & listing index — with links, so you can read the paper yourself. We test nothing and give no medical or skincare advice. A 510(k) clearance is a safety-and-equivalence review, not a performance ranking, an endorsement, or an "FDA approval." If a brand publishes a K-number or listing that changes a row, the page changes — the record wins.

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