DERMAWAVE 5000 COMBI MAX SYSTEM— 510(k) K040121

Substantially Equivalent

Dermawave, LLC

FDA 510(k) clearance K040121 for DERMAWAVE 5000 COMBI MAX SYSTEM, Substantially Equivalent on 2004-03-17. Applicant: Dermawave, LLC. Device class: 2.

Clearance details

Applicant: Dermawave, LLC
Product code: Code IMG
Device class: Class 2
Regulation: 21 CFR 890.5860
Advisory panel: Physical Medicine
Date received: 2004-01-20
Decision date: 2004-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Loxahatchee, FL, US

Download summary PDF View on FDA.gov ↗

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