LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)— 510(k) K261052
Substantially EquivalentGuangdong Newdermo Biotech Co., Ltd.
FDA 510(k) clearance K261052 for LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA), Substantially Equivalent on 2026-06-29. Applicant: Guangdong Newdermo Biotech Co., Ltd.. Device class: 2.
Summary
Guangdong Newdermo Biotech's LED Light Therapy Masks come in two models: the LED Face Mask Pro (FAC08NA) and the LED Chest Mask Pro (FAC09NA). They're filed under OHS, which the code name gives as light-based over-the-counter wrinkle reduction.
Class II, 21 CFR 878.4810. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Newdermo filed from Guangzhou, China. Review took 90 calendar days (March 31 to June 29, 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 →
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