K192620 is an FDA 510(k) clearance for the SNA-001 Silver Photoparticle Topical Gel. This device is classified as a Laser Absorbing Particles (Class II - Special Controls, product code QCY).
Submitted by Sienna Biopharmaceuticals, Inc. (Westlake Village, US). The FDA issued a Cleared decision on August 12, 2020, 324 days after receiving the submission on September 23, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4810. Particles Are Applied To The Target Tissue(s) For The Purpose Of Absorbing Laser/light Energy..
| 510(k) Number | K192620 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2019 |
| Decision Date | August 12, 2020 |
| Days to Decision | 324 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QCY - Laser Absorbing Particles |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4810 |
| Definition | Particles Are Applied To The Target Tissue(s) For The Purpose Of Absorbing Laser/light Energy. |