510(k) clearance
LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))
- 510(k) number
- K261370
- Applicant
- Guangdong Newdermo Biotech Co., Ltd.
- Decision date
- Sep 16, 2026
- Date received
- Apr 27, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- NFO
- Device type
- Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- Device class
- Class II
- Regulation
- 21 CFR 882.5890
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- Guangzhou, CN