K023678 is an FDA 510(k) clearance for the DIMISIL SCAR GEL, a Elastomer, Silicone, For Scar Management (Class I — General Controls, product code MDA), submitted by Aesthetic and Reconstructive Technologies, Inc. (Paso Robles, US). The FDA issued a Cleared decision on January 23, 2003, 83 days after receiving the submission on November 1, 2002. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4025.
| 510(k) Number | K023678 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 01, 2002 |
| Decision Date | January 23, 2003 |
| Days to Decision | 83 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 |