K242363 is an FDA 510(k) clearance for the HIGHERDOSE Red Light Hat (HG-120K). This device is classified as a Laser, Comb, Hair (Class II - Special Controls, product code OAP).
Submitted by Shenzhen Kaiyan Medical Equipment Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 20, 2024, 103 days after receiving the submission on August 9, 2024.
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 | K242363 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2024 |
| Decision Date | November 20, 2024 |
| Days to Decision | 103 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 |