K213025 is an FDA 510(k) clearance for the Laser hair growth helmet. This device is classified as a Laser, Comb, Hair (Class II - Special Controls, product code OAP).
Submitted by Kam Yuen Plastic Products , Ltd. (Zhongshan, CN). The FDA issued a Cleared decision on May 12, 2022, 233 days after receiving the submission on September 21, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 890.5500. Promote Hair Growth In Males With Androgenic Alopecia And Norwood Hamilton Classification Of Iia To V.
| 510(k) Number | K213025 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 2021 |
| Decision Date | May 12, 2022 |
| Days to Decision | 233 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OAP - Laser, Comb, Hair |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5500 |
| Definition | Promote Hair Growth In Males With Androgenic Alopecia And Norwood Hamilton Classification Of Iia To V |