OYW · Laser, Cellulite Appearance
General, Plastic Surgery · 21 CFR 878.4810 · Class 2
Overview
| Product Code | OYW |
|---|---|
| Device Name | Laser, Cellulite Appearance |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 3rd-Party Reviewable | Yes |
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 |
|---|---|---|---|---|
| K123407 | CELLULAZE LASER | Cynosure, Inc. | Mar 29, 2013 | SESE |
| K102541 | CYNOSURE CELLULAZE LASER | Cynosure, Inc. | Jan 26, 2012 | SESE |
Top Applicants
- Cynosure, Inc. — 2 clearances
