QLASER SYSTEM— 510(k) K080513

Substantially Equivalent

2035, Inc.

FDA 510(k) clearance K080513 for QLASER SYSTEM, Substantially Equivalent on 2009-01-30. Applicant: 2035, Inc.. Device class: 2.

Clearance details

Applicant: 2035, Inc.
Product code: Code NHN
Device class: Class 2
Regulation: 21 CFR 890.5500
Advisory panel: Physical Medicine
Date received: 2008-02-25
Decision date: 2009-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, CO, US

Download summary PDF View on FDA.gov ↗

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