K083718 is an FDA 510(k) clearance for the BEAU RX SCAR CARE GEL, a Elastomer, Silicone, For Scar Management (Class I — General Controls, product code MDA), submitted by Beau RX Solutions, LLC (Melbourne Beach, US). The FDA issued a Cleared decision on January 26, 2009, 42 days after receiving the submission on December 15, 2008. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4025.
| 510(k) Number | K083718 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 15, 2008 |
| Decision Date | January 26, 2009 |
| Days to Decision | 42 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 |