Sebacia Microparticles
FDA 510(k) clearance K181518 · decided 2018-09-06
Clearance details
- K-number
- K181518
- Device name
- Sebacia Microparticles
- Applicant
- Sebacia, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-06-08
- Decision date
- 2018-09-06
- Days to decision
- 90 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
- Duluth, GA, 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 |
|---|---|---|
| SNA-001 Silver Photoparticle Topical Gel (K192620) | Sienna Biopharmaceuticals, Inc. | 2020-08-12 |
Recalls involving this device
No recalls on record reference this clearance.