| Device Classification Name |
Light Based Over The Counter Wrinkle Reduction
|
| 510(k) Number |
K251871 |
| Device Name |
FEATHER 01 02 03 04 (Model:01) |
| Applicant |
| Heat IN A Click, LLC |
| Numiere 1975 Tigertail Blvd. |
|
Dania,
FL
33004
|
|
| Applicant Contact |
Guy Levi |
| Correspondent |
| Guangzhou GLOMED Biological Technology Co., Ltd. |
| 2231, Bldg. 1, Rui Feng Center, Kaichuang Rd., Huangpu Distr |
|
Guangzhou,
CN
510530
|
|
| Correspondent Contact |
Cassie Lee |
| Regulation Number | 878.4810 |
| Classification Product Code |
|
| Date Received | 06/18/2025 |
| Decision Date | 08/15/2025 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
General & Plastic Surgery
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|