K253669 is an FDA 510(k) clearance for the TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300), 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 January 23, 2026, 63 days after receiving the submission on November 21, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 890.5500.
| 510(k) Number | K253669 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 21, 2025 |
| Decision Date | January 23, 2026 |
| Days to Decision | 63 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 |