Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4810](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4810) → ORK — Laser Assisted Lipolysis

# ORK · Laser Assisted Lipolysis

_General, Plastic Surgery · 21 CFR 878.4810 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ORK

## Overview

- **Product Code:** ORK
- **Device Name:** Laser Assisted Lipolysis
- **Regulation:** [21 CFR 878.4810](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4810)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## 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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ORK/K090754.md) | LIPOCONTROL | Osyris Medical | Jan 21, 2011 | SESE |

## Top Applicants

- Osyris Medical — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ORK](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ORK)

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