I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V)— 510(k) K101366

Name: FDA 510(k) clearance K101366
Creator: U.S. Food and Drug Administration
Published: 2010-09-17

Substantially Equivalent

Chromogenex Technologies, Ltd.

FDA 510(k) clearance K101366 for I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V), Substantially Equivalent on 2010-09-17. Applicant: Chromogenex Technologies, Ltd.. Device class: 2.

Clearance details

Applicant: Chromogenex Technologies, Ltd.
Product code: Code NUV
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2010-05-17
Decision date: 2010-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Llanelli, Carmarthenshire, GB

Download summary PDF View on FDA.gov ↗

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