← Product Code [OLI](/productcode/OLI) · DEN090008

# ERCHONIA ML SCANNER (MLS) (DEN090008)

_Erchonia Medical · OLI · Aug 24, 2010 · General, Plastic Surgery · DENG_

**Canonical URL:** https://fda-staging.innolitics.com/device/DEN090008

## Device Facts

- **Applicant:** Erchonia Medical
- **Product Code:** [OLI](/productcode/OLI.md)
- **Decision Date:** Aug 24, 2010
- **Decision:** DENG
- **Submission Type:** Post-NSE
- **Regulation:** 21 CFR 878.5400
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.

## Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.

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**Source:** [https://fda-staging.innolitics.com/device/DEN090008](https://fda-staging.innolitics.com/device/DEN090008)

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