The short answer: Photira is not asking you to take our word for anything. Every claim below is independently verifiable — the FDA clearance on the FDA's own public database, and the device specifications listed exactly as filed.
FDA 510(k) Clearance
| Clearance number | K254007 |
| Clearance type | 510(k) Premarket Notification |
| Regulation | 21 CFR 878.4810 |
| Indications for use | Treatment of wrinkles and mild to moderate acne |
| Basis | Substantial equivalence to legally marketed predicate devices |
| Marketing status | Over-the-counter, no prescription needed |
Verify this clearance yourself by searching K254007 on the FDA's public 510(k) database. This takes under a minute and doesn't require our cooperation — it's a public government record.
Device Specifications
| LED count | 144 medical-grade LEDs |
| Red light | 620–625nm |
| Blue light | 460–470nm |
| Near-infrared | 850–853nm (combines with red mode) |
| Material | Medical-grade silicone |
| Battery | 2000mAh, Type-C rechargeable, cordless in use |
| Timer settings | 5 / 10 / 15 minutes |
| Recommended use | 10 minutes per session, 3 times per week |
| Weight | Approx. 355g |
| Power | Approx. 2.9W |
What "FDA-cleared" does and doesn't mean
FDA 510(k) clearance means the FDA reviewed the device and determined it is substantially equivalent to a legally marketed predicate device for a specific indication — in Photira's case, wrinkles and mild-to-moderate acne. It is not the same as FDA "approval" (a separate, more extensive process usually reserved for drugs and higher-risk devices), and it is not a guarantee of individual results. We use the term "cleared" specifically, and precisely, for this reason.
Why we publish this page
Photira is a new brand. We don't have hundreds of reviews yet, and we're not asking you to trust our marketing copy. What we can offer instead is a clearance number you can look up in an official government database in under a minute, and exact specifications rather than vague claims. If anything on this page doesn't match what you find in the FDA's own records, we want to know — contact us at support@photiraskin.com.
Manufacturing
Photira's LED Light Therapy Mask is manufactured by Shenzhen KKS Silicone & Electronic Co., Ltd., under private-label authorization, model KKS-225.
FAQ
How do I verify Photira's FDA clearance myself?
Visit the FDA's 510(k) Premarket Notification database at accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm and search for K254007. The listing will show the clearance holder, date, and indication for use.
What's the difference between "FDA cleared" and "FDA approved"?
Clearance (510(k)) means a device is substantially equivalent to an existing legally marketed device. Approval is a separate, more rigorous process typically used for drugs and higher-risk (Class III) devices. Photira is FDA-cleared, not FDA-approved — we use this term precisely.
Can Photira be used for severe or cystic acne?
No — the clearance specifically covers mild to moderate acne. For severe or cystic acne, consult a dermatologist.