Yes. CurrentBody's LED mask line appears in the FDA 510(k) database — for example, K242593 (applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.; device: "CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask"; FDA decision date: February 14, 2025). CurrentBody also describes its Series 2 mask as an "FDA cleared LED face mask for advanced anti-aging" on currentbody.us.
The listings in the FDA database
A 510(k) database search for CurrentBody's mask line on October 7, 2026 returned:
- K242593 — Shenzhen Kaiyan Medical Equipment Co., Ltd.; "CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask"; decided February 14, 2025
- K260715 — The Beauty Tech Group, Ltd.; "CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)"; decided June 3, 2026 (a newer listing, likely covering a newer mask generation)
Related CurrentBody-brand listings (different devices): K232424 ("CurrentBody Skin RF," El Global Trade, Ltd.) and K251017/K230336 (hair-growth devices). As always, match the K number to the specific product you're buying.
How to verify it yourself (2 minutes)
- Go to accessdata.fda.gov → 510(k) Premarket Notification database.
- Search K242593 (or K260715 for the newer mask generation) — the K number, not the brand name, since FDA records use the applicant and model designation.
- Confirm applicant, device name, and decision date match.
The same check works for any brand. Photira's entry, for reference: K254007, applicant "SZ KKS Silicone&Electronic Co., Ltd.," models KKS-225, KKS-280, KKS-281.
Price context (as of October 7, 2026)
The CurrentBody Series 2 LED mask is listed at $469.99 on currentbody.us. Photira's $199 everyday price covers a different configuration — red 630 nm, near-infrared 850 nm, and blue 465 nm modes, FDA-cleared for wrinkles and mild-to-moderate acne under K254007.
Series 3 is the current flagship: $569.99 on currentbody.us (as of October 9, 2026), 750 LEDs, six wavelengths (415/532/590/633/830/1072 nm), MyDose app; a Neck & Décolletage Series 3 launched alongside it.
Frequently asked questions
What is CurrentBody's 510(k) number?
K242593 is the key listing for the LED mask line (applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.; device: "CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask"; decided February 14, 2025). A newer listing, K260715, was decided June 3, 2026.
Is the Series 2 mask specifically covered?
CurrentBody markets the Series 2 as "FDA cleared," and K242593's device name ("LED 4 in 1 Zone Facial Mapping Mask") corresponds to that mask generation. The newer K260715 appears to cover a subsequent generation. When in doubt, ask CurrentBody which K number covers the exact model you're buying.
Does FDA-cleared mean FDA-approved?
No. Clearance via the 510(k) pathway means the FDA found the device substantially equivalent to a predicate device. Approval (PMA) is a separate, more extensive review for higher-risk devices.
How much does the CurrentBody Series 2 cost?
$469.99 on currentbody.us as of October 7, 2026.
How can I verify any LED mask's FDA clearance?
Search the K number — not the brand name — in the FDA 510(k) database at accessdata.fda.gov, and confirm the applicant, device/model name, and decision date. Example: Photira K254007 (applicant "SZ KKS Silicone&Electronic Co., Ltd.," models KKS-225, KKS-280, KKS-281).