Photira LED Face Mask: Specifications & Facts

Last updated: October 6, 2026

This page lists the verified specifications, FDA clearance details, and usage facts for the Photira LED Light Therapy Face Mask (manufacturer model KKS-225). For the full clearance documents and test reports, see Clinical Transparency.

At a glance

FDA cleared vs. FDA approved

Photira is FDA 510(k) cleared, not FDA approved: 510(k) clearance means the FDA found the device substantially equivalent to a legally marketed device, while "approval" refers to the separate Premarket Approval (PMA) pathway used for higher-risk devices.

Modes and what each is used for

The mask runs one selectable mode at a time. All wavelengths are never on simultaneously, and blue cannot be combined with near-infrared.

• Red (630 ± 5 nm): used for wrinkles and fine lines.
• Blue (465 ± 5 nm): used for mild to moderate acne.
• Red + Near-Infrared (630 ± 5 nm + 850 ± 5 nm): red light with an added near-infrared wavelength. The FDA indication covers wrinkles and mild to moderate acne; near-infrared does not have a separate indication.

More detail: A dermatologist explains the LED mask modes.

How to verify the clearance

• Step 1: Open the FDA 510(k) database entry for K254007.
• Step 2: Check the decision date (February 12, 2026), product codes (OHS, OLP), the device name "LED Light Therapy Silicone Face Mask", and the applicant SZ KKS Silicone & Electronic Co., Ltd. (the manufacturer of model KKS-225).
• Step 3: Compare the listed Indications for Use with the text quoted on this page, and review the documents on our Clinical Transparency page.

Safety notes

• Not for severe acne or cystic acne; see a dermatologist for these conditions.
• Stop use if irritation persists.
• Talk to a doctor before use if you are pregnant, take photosensitizing medication (such as isotretinoin), or have an eye condition.
• Use the included eye protection as described in the user manual.

FAQ

Is Photira FDA approved?

No. The Photira LED Light Therapy Face Mask is FDA 510(k) cleared (K254007), not FDA approved. 510(k) clearance means the FDA found the device substantially equivalent to a legally marketed device; "approval" refers to the separate Premarket Approval (PMA) pathway used for higher-risk devices.

What is the Photira LED face mask cleared for?

Its FDA Indications for Use state: "LED Light Therapy Silicone Face Mask is an over the counter device that is intended to use LED light for the treatment of wrinkles and mild to moderate acne." Product codes OHS and OLP; decision date February 12, 2026.

What wavelengths does the Photira mask use?

Three selectable modes, used one at a time: Red 630 ± 5 nm; Blue 465 ± 5 nm; and Red + Near-Infrared 630 ± 5 nm + 850 ± 5 nm. Blue cannot be combined with near-infrared, and all wavelengths are never on at the same time.

How long and how often should I use it?

The manufacturer recommends 10 minutes per session, 3 times per week, on clean, dry skin.

What is the irradiance and how was it measured?

Per the manufacturer test report: Red 8.0 mW/cm², Blue 7.66 mW/cm², Red + NIR 11.0 mW/cm². The whole mask was measured in a 1.5 m integrating sphere with a HAAS-1200 spectroradiometer (GB/T 7922-2023), and total radiant flux was divided by the mask's 321 cm² illuminated area. These are area averages, not peak or per-point readings, and there is no measurement distance.

Why does the FDA database list SZ KKS instead of Photira?

The 510(k) clearance K254007 is held by the device's manufacturer, SZ KKS Silicone & Electronic Co., Ltd., so the FDA database shows SZ KKS as the applicant. Photira is the US brand of that cleared device (manufacturer model KKS-225), sold directly to consumers at photiraskin.com for $199 with the manufacturer's private-label authorization. The model number KKS-225 is printed on the product. SZ KKS itself does not sell to the public, which is why some directories list K254007 as not available for retail sale.

Buy or learn more: Photira LED Light Therapy Face Mask product page.