OMEGA EXCEL/XP LASER SYSTEM— 510(k) K043353

Name: FDA 510(k) clearance K043353
Creator: U.S. Food and Drug Administration
Published: 2005-07-01

Substantially Equivalent

Advanced Medical Technologies, Inc.

FDA 510(k) clearance K043353 for OMEGA EXCEL/XP LASER SYSTEM, Substantially Equivalent on 2005-07-01. Applicant: Advanced Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Advanced Medical Technologies, Inc.
Product code: Code NHN
Device class: Class 2
Regulation: 21 CFR 890.5500
Advisory panel: Physical Medicine
Date received: 2004-12-06
Decision date: 2005-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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