THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM— 510(k) K050342

Name: FDA 510(k) clearance K050342
Creator: U.S. Food and Drug Administration
Published: 2005-07-11

Substantially Equivalent

Theralase, Inc.

FDA 510(k) clearance K050342 for THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM, Substantially Equivalent on 2005-07-11. Applicant: Theralase, Inc.. Device class: 2.

Clearance details

Applicant: Theralase, Inc.
Product code: Code NHN
Device class: Class 2
Regulation: 21 CFR 890.5500
Advisory panel: Physical Medicine
Date received: 2005-02-11
Decision date: 2005-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Markham, Ontario, CA

Download summary PDF View on FDA.gov ↗

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