SNA-001 Silver Photoparticle Topical Gel
FDA 510(k) clearance K192620 · decided 2020-08-12
Clearance details
- K-number
- K192620
- Device name
- SNA-001 Silver Photoparticle Topical Gel
- Applicant
- Sienna Biopharmaceuticals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-09-23
- Decision date
- 2020-08-12
- Days to decision
- 324 days
- Clearance type
- Traditional
- Product code
- QCY
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Westlake Village, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Sebacia Microparticles (K181518) | Sebacia, Inc. | 2018-09-06 |
Recalls involving this device
No recalls on record reference this clearance.