Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K223544
LED light therapy mask (FM-01, FM-02, FM-03) · Guangdong Newdermo Biotech Co., Ltd. · decided 2023-02-23 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| VOGUENOW | FM-02 | Guangdong Newdermo Biotech Co.,Ltd. | ILP OHS OLP | 06974020960948 |
| Brookstone | FM-01 | Guangdong Newdermo Biotech Co.,Ltd. | ILP OHS OLP | 06974020961273 |
| (unnamed) | FM-02 | Guangdong Newdermo Biotech Co.,Ltd. | ILY OHS OLP | 06974020961044 |
| (unnamed) | FM-02 | Guangdong Newdermo Biotech Co.,Ltd. | ILY OHS OLP | 06974020961075 |
| Silk'n | FM-02 | Silkn Beauty Ltd. | ILP OHS OLP | 17290019840043 |
| INIA | FM-02 | Guangdong Newdermo Biotech Co.,Ltd. | ILY OHS OLP | 06974020961020 |
| WONDER FAMILY | FM-03 | Guangdong Newdermo Biotech Co.,Ltd. | ILP OHS OLP | 06974020961013 |
| (unnamed) | FM-03 | Guangdong Newdermo Biotech Co.,Ltd. | ILY OHS OLP | 06974020961082 |
| (unnamed) | FM-02 | Guangdong Newdermo Biotech Co.,Ltd. | ILY OHS OLP | 06974020961105 |
| kingdo | FM-02 | Guangdong Newdermo Biotech Co.,Ltd. | ILP OHS OLP | 06974020960962 |
| AURA | FM-02 | Guangdong Newdermo Biotech Co.,Ltd. | ILP OHS OLP | 06974020960993 |
| Silk'n | FM-03 | Silkn Beauty Ltd. | ILP OHS OLP | 17290019840050 |
| Brookstone | FM-01 | Guangdong Newdermo Biotech Co.,Ltd. | ILP OHS OLP | 06974020961280 |
| Newdermo | FM-01 | Guangdong Newdermo Biotech Co.,Ltd. | ILP OHS OLP | 06974020960917 |
| kingdo | FM-02 | Guangdong Newdermo Biotech Co.,Ltd. | ILP OHS OLP | 06974020960979 |
| Silk'n | FM-02 | Silkn Beauty Ltd. | ILP OHS OLP | 18712856075024 |
| AURA | FM-02 | Guangdong Newdermo Biotech Co.,Ltd. | ILY OHS OLP | 06974020960955 |
| (unnamed) | FM-02 | Guangdong Newdermo Biotech Co.,Ltd. | ILY OHS OLP | 06974020961037 |
| VOGUENOW | FM-02 | Guangdong Newdermo Biotech Co.,Ltd. | ILP OHS OLP | 06974020960986 |
| (unnamed) | FM-01 | Guangdong Newdermo Biotech Co.,Ltd. | ILY OHS OLP | 06974020961068 |
| WONDER FAMILY | FM-02 | Guangdong Newdermo Biotech Co.,Ltd. | ILP OHS OLP | 06974020961006 |