ACCELAWAVE SYSTEM— 510(k) K082484

Substantially Equivalent

Genesis Biosystems, Inc.

FDA 510(k) clearance K082484 for ACCELAWAVE SYSTEM, Substantially Equivalent on 2008-09-12. Applicant: Genesis Biosystems, Inc.. Device class: 2.

Clearance details

Applicant: Genesis Biosystems, Inc.
Product code: Code ONF
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2008-08-28
Decision date: 2008-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lewisville, TX, US

Download summary PDF View on FDA.gov ↗

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