LED Light Therapy Masks (LumiLips FAC07NA)— 510(k) K260202
Substantially EquivalentGuangdong Newdermo Biotech Co., Ltd.
FDA 510(k) clearance K260202 for LED Light Therapy Masks (LumiLips FAC07NA), Substantially Equivalent on 2026-03-23. Applicant: Guangdong Newdermo Biotech Co., Ltd.. Device class: 2.
Summary
Guangdong Newdermo Biotech's LED Light Therapy Masks (LumiLips FAC07NA) are filed under OHS, light-based over-the-counter wrinkle reduction. The record doesn't describe the masks beyond that name and code name.
Class II, 21 CFR 878.4810. It was a Traditional 510(k), and General and Plastic Surgery is both the classification panel and the review panel.
Guangdong Newdermo Biotech filed from Guangzhou, China. The decision came 59 calendar days after FDA received it (January 23 to March 23, 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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