meddevicedb.com FDA Device Reference

ERCHONIA ML SCANNER (MLS)

DEN090008 Class II Post-NSE
Decision Date
2010-08-24
Sponsor / Applicant
Erchonia Medical

Technical Specification

510(k) Submission ID DEN090008
Product Code OLI
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.5400
Decision Date 2010-08-24
Clearance Pathway Post-NSE

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

ERCHONIA ML SCANNER (MLS) received FDA 510(k) clearance under submission number DEN090008, sponsored by Erchonia Medical. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2010-08-24.

Classification & Regulation

This clearance is catalogued under FDA product code OLI and 21 CFR 878.5400, within the General, Plastic Surgery review panel as a Class II device.