K222748 is an FDA 510(k) clearance for the ShiNeo Silicone Implant. This device is classified as a Elastomer, Silicone Block (Class II - Special Controls, product code MIB).
Submitted by Shineo Technology Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on December 23, 2022, 102 days after receiving the submission on September 12, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 874.3620.
| 510(k) Number | K222748 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2022 |
| Decision Date | December 23, 2022 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MIB - Elastomer, Silicone Block |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3620 |