LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)
Device Facts
| Record ID | K260946 |
|---|---|
| Device Name | LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) |
| Applicant | Guangdong Newdermo Biotech Co., Ltd. |
| Product Code | OHS · General, Plastic Surgery |
| Decision Date | Jun 18, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
Regulatory Classification
Identification
(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
