510(k) K261370
K261370 is an FDA 510(k) premarket notification submitted by Guangdong Newdermo Biotech Co., Ltd. for the device "LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))". The FDA issued a decision of Substantially Equivalent on September 16, 2026. The device falls under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes), a Class II device regulated under 21 CFR 882.5890. Guangdong Newdermo Biotech Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 16, 2026
- Date Received
- April 27, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type