K111733 is an FDA 510(k) clearance for the CORELEADER SCAR-DIMMER, a Elastomer, Silicone, For Scar Management (Class I — General Controls, product code MDA), submitted by Coreleader Biotech Co., Ltd. (New Taipei, Taiwan, TW). The FDA issued a Cleared decision on September 22, 2011, 93 days after receiving the submission on June 21, 2011. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4025.
| 510(k) Number | K111733 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 21, 2011 |
| Decision Date | September 22, 2011 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MDA — Elastomer, Silicone, For Scar Management |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4025 |