LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))— 510(k) K261370
Substantially EquivalentGuangdong Newdermo Biotech Co., Ltd.
FDA 510(k) clearance K261370 for LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)), Substantially Equivalent on 2026-09-16. Applicant: Guangdong Newdermo Biotech Co., Ltd.. Device class: 2.
Summary
Guangdong Newdermo Biotech Co., Ltd. filed LED Light Therapy Masks, model LED Face Mask Pulse (FAC06NA), under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes). The record gives the model number and no other detail.
Class II, 21 CFR 882.5890. Neurology is both the classification panel and the review panel. It was a Traditional 510(k), decided Substantially Equivalent.
Newdermo filed from Guangzhou, China. The decision came 142 calendar days after FDA received it (April 27 to September 16, 2026).
Clearance details
- Applicant
- Guangdong Newdermo Biotech Co., Ltd.
- Product code
- Product code NFO
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guangzhou, CN
Recent devices under product code NFO
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