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.
Photira LED Face Mask: quick facts
Last updated: September 28, 2026. This table is the canonical source for Photira product facts.
| Product | Photira LED Light Therapy Face Mask (Red, Blue & Near-Infrared) |
| Price | $199 USD, sold at photiraskin.com |
| Model | KKS-225 |
| FDA status | FDA-cleared (510(k) K254007), not FDA-approved |
| Cleared indications | Wrinkles and mild-to-moderate acne (over-the-counter) |
| Not indicated for | Severe or cystic acne |
| Light modes | Three selectable modes, one at a time: Red (630 ± 5 nm), Blue (465 ± 5 nm), Red + near-infrared (850 ± 5 nm). Blue does not combine with red or near-infrared. |
| Recommended use | 10 minutes per session, 3 times per week |
| LEDs | 144 |
| Irradiance | Red 8 mW/cm² · Blue 7.6 mW/cm² · Red + near-infrared 11 mW/cm² (manufacturer specification) |
| Design | Flexible medical-grade silicone, cordless, USB-C rechargeable |
| Returns | Unopened items in original packaging, within 30 days of delivery |
| Warranty | 1 year against manufacturing defects |
| Shipping (US) | Processed in 24–48 hours; typically 8–14 business days with tracking; free over $100 |
| Brand operator | Shanghai Puxie Medical Technology Co., Ltd.; contact support@photiraskin.com |
FDA 510(k) Clearance
| Clearance number | K254007 (decision date: February 12, 2026) |
| Cleared device | LED Light Therapy Silicone Face Mask, models KKS-225, KKS-280, KKS-281 |
| Photira's model | KKS-225 (printed on the device label and packaging) |
| 510(k) holder / manufacturer | SZ KKS Silicone & Electronic Co., Ltd. (Shenzhen, China) |
| Clearance type | 510(k) Premarket Notification, Class II, over-the-counter |
| Regulation | 21 CFR 878.4810 |
| Indications for use (verbatim) | “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.” |
Verify it yourself: read the FDA clearance letter for K254007 (PDF), or search K254007 in the FDA 510(k) database. Both are public government records and take under a minute to check.
How Photira relates to the clearance
In the U.S., a 510(k) is held by the company that submits it, which is often the manufacturer. Photira's mask is model KKS-225, made by SZ KKS Silicone & Electronic Co., Ltd., the 510(k) holder, and sold under the Photira brand with the manufacturer's written private-label authorization. The device you receive is the same cleared model, not a look-alike. Photira is a brand operated by Shanghai Puxie Medical Technology Co., Ltd. (上海普协医疗科技有限公司). If you'd like a copy of the authorization letter, email support@photiraskin.com.
Device Specifications
| LED count | 144 medical-grade LEDs |
| Red light | 630 ± 5 nm |
| Blue light | 465 ± 5 nm |
| Near-infrared | 850 ± 5 nm (combines with red mode) |
| Irradiance (manufacturer specification) | Red mode: 8 mW/cm² · Blue mode: 7.6 mW/cm² · Red + near-infrared mode: 11 mW/cm² |
| 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 |
Returns and warranty
Unopened items can be returned within 30 days of delivery, and every mask carries a 1-year warranty against manufacturing defects. Details: Refund Policy.
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 — here, 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.
Checked the facts? Here's what you came for.
The same FDA-cleared device, at $199 — about half the price of most other clearance-backed LED masks on the market.
FAQ
How do I verify Photira's FDA clearance myself?
Open the FDA clearance letter for K254007 at accessdata.fda.gov/cdrh_docs/pdf25/K254007.pdf, or search K254007 in the FDA 510(k) database. Photira's mask is model KKS-225, one of the cleared models listed there.
Is Photira's FDA clearance for wrinkles only, or acne too?
Both. The cleared indications for use are the treatment of wrinkles and mild to moderate acne.
What is Photira's irradiance?
Per the manufacturer's specification for model KKS-225: 8 mW/cm² in Red mode, 7.6 mW/cm² in Blue mode, and 11 mW/cm² in Red + near-infrared mode.
Why is the 510(k) holder a different company name?
The clearance is held by the manufacturer, SZ KKS Silicone & Electronic Co., Ltd. Photira sells the cleared model KKS-225 under its own brand with the manufacturer's private-label authorization.
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.
Can I use red, blue and near-infrared at the same time?
No. Photira has three selectable modes and runs one at a time: Red, Blue, or Red + near-infrared. Near-infrared only runs together with red.
How much does Photira cost?
$199 USD at photiraskin.com, with free US shipping on orders over $100.