QCY · Laser Absorbing Particles
General, Plastic Surgery · 21 CFR 878.4810 · Class 2
Overview
| Product Code | QCY |
|---|---|
| Device Name | Laser Absorbing Particles |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
Classification Rationale
(1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K192620 | SNA-001 Silver Photoparticle Topical Gel | Sienna Biopharmaceuticals, Inc. | Aug 12, 2020 | SESE |
| K181518 | Sebacia Microparticles | Sebacia, Inc. | Sep 6, 2018 | SESE |
Top Applicants
- Sebacia, Inc. — 1 clearance
- Sienna Biopharmaceuticals, Inc. — 1 clearance
