ORK · Laser Assisted Lipolysis
General, Plastic Surgery · 21 CFR 878.4810 · Class 2
Overview
| Product Code | ORK |
|---|---|
| Device Name | Laser Assisted Lipolysis |
| 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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K090754 | LIPOCONTROL | Osyris Medical | Jan 21, 2011 | SESE |
Top Applicants
- Osyris Medical — 1 clearance
