510(k) K192620
- Device
- SNA-001 Silver Photoparticle Topical Gel
- Applicant
- Sienna Biopharmaceuticals, Inc.
- 510(k) number
- K192620
- Product code
- QCY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-08-12
- Date received
- 2019-09-23
- 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
- Paul Lizzul
- Address
- 30699 Russell Ranch Rd., Suite 140 Westlake Village CA US 91362 91362
FDA Registration Numbers#
- 3021159346
Source Documents#
Other 510(k) Records For Product Code QCY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K181518 | Sebacia Microparticles | Sebacia, Inc. | 2018-09-06 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases