K232593 is an FDA 510(k) clearance for the FITme Customized Silicone Implant. This device is classified as a Prosthesis, Chin, Internal (Class II - Special Controls, product code FWP).
Submitted by Keosan Trading Co. (Seoul, KR). The FDA issued a Cleared decision on November 22, 2023, 89 days after receiving the submission on August 25, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3550.
| 510(k) Number | K232593 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2023 |
| Decision Date | November 22, 2023 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FWP - Prosthesis, Chin, Internal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3550 |