LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)— 510(k) K260946
Substantially EquivalentGuangdong Newdermo Biotech Co., Ltd.
FDA 510(k) clearance K260946 for LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K), Substantially Equivalent on 2026-06-18. Applicant: Guangdong Newdermo Biotech Co., Ltd.. Device class: 2.
Summary
Guangdong Newdermo Biotech's LED Light Therapy Mask is listed in six models: K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, and FM-09K. It's filed under OHS, which the code name gives as light-based over-the-counter wrinkle reduction, and the record doesn't say how the models differ.
Class II, 21 CFR 878.4810. General and Plastic Surgery is both the classification panel and the review panel. The submission was a Traditional 510(k).
Newdermo filed from Guangzhou, China. The decision came 87 calendar days after receipt (March 23 to June 18, 2026).
Clearance details
- Applicant
- Guangdong Newdermo Biotech Co., Ltd.
- Product code
- Product code OHS
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guangzhou, CN
Recent devices under product code OHS
view allMore clearances from Guangdong Newdermo Biotech Co., Ltd.
view allAdverse events under product code OHS
product code OHS- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.