The following data is part of a premarket notification filed by Sienna Biopharmaceuticals, Inc. with the FDA for Sna-001 Silver Photoparticle Topical Gel.
| Device ID | K192620 |
| 510k Number | K192620 |
| Device Name: | SNA-001 Silver Photoparticle Topical Gel |
| Classification | Laser Absorbing Particles |
| Applicant | Sienna Biopharmaceuticals, Inc. 30699 Russell Ranch Road, Suite 140 Westlake Village, CA 91362 |
| Contact | Paul Lizzul |
| Correspondent | Pedro Medrano Sienna Biopharmaceuticals, Inc. 30699 Russell Ranch Road, Suite 140 Westlake Village, CA 91362 |
| Product Code | QCY |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-23 |
| Decision Date | 2020-08-12 |