K251012 is an FDA 510(k) clearance for the TRUDERMAL Pro (ZLD-390). This device is classified as 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 August 14, 2025, 134 days after receiving the submission on April 2, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4810. Use Of Light Based Treatment To Reduce Wrinkles On The Body In General Or Specific Anatomical Locations Depending On The Information Provided..
| 510(k) Number | K251012 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 2025 |
| Decision Date | August 14, 2025 |
| Days to Decision | 134 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. |