RESURFX 1565NM LASER MODULE— 510(k) K130028

Substantially Equivalent

Lumenis, Ltd.

FDA 510(k) clearance K130028 for RESURFX 1565NM LASER MODULE, Substantially Equivalent on 2013-09-03. Applicant: Lumenis, Ltd..

Clearance details

Applicant: Lumenis, Ltd.
Product code: Code ONG
Advisory panel: General, Plastic Surgery
Date received: 2013-01-03
Decision date: 2013-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Binyamina, IL

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