STRATAPULSE TS AND STRATAPULSE— 510(k) K090837

Name: FDA 510(k) clearance K090837
Creator: U.S. Food and Drug Administration
Published: 2009-06-17

Substantially Equivalent

Advanced Medical Photonics

FDA 510(k) clearance K090837 for STRATAPULSE TS AND STRATAPULSE, Substantially Equivalent on 2009-06-17. Applicant: Advanced Medical Photonics. Device class: 2.

Clearance details

Applicant: Advanced Medical Photonics
Product code: Code ONF
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2009-03-27
Decision date: 2009-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Davis, CA, US

Download summary PDF View on FDA.gov ↗

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