K251781 is an FDA 510(k) clearance for the KALA MINI 2.0 (KALA-04), a Light Based Over The Counter Wrinkle Reduction (Class II — Special Controls, product code OHS), submitted by Shenzhen Kaiyan Medical Equipment Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 4, 2025, 85 days after receiving the submission on June 11, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.
| 510(k) Number | K251781 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 11, 2025 |
| Decision Date | September 04, 2025 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OHS — Light Based Over The Counter Wrinkle Reduction |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4810 |
| Definition | Use Of Light Based Treatment To Reduce Wrinkles On The Body In General Or Specific Anatomical Locations Depending On The Information Provided. |