510(k) K181518
- Device
- Sebacia Microparticles
- Applicant
- Sebacia, Inc.
- 510(k) number
- K181518
- Product code
- QCY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-09-06
- Date received
- 2018-06-08
- Regulation
- 878.4810
- Classification name
- Laser Absorbing Particles
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Todd J. Meyer
- Address
- 2905 Premiere Pkwy., Suite 150 Duluth GA US 30097 30097
FDA Registration Numbers#
- 3021159346
Source Documents#
Other 510(k) Records For Product Code QCY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192620 | SNA-001 Silver Photoparticle Topical Gel | Sienna Biopharmaceuticals, Inc. | 2020-08-12 |
Legacy Summary#
summary
FDA Review#
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