RESURFX 1565NM LASER MODULE— 510(k) K130028
Substantially EquivalentLumenis, Ltd.
FDA 510(k) clearance K130028 for RESURFX 1565NM LASER MODULE, Substantially Equivalent on 2013-09-03. Applicant: Lumenis, Ltd.. Device class: 2.
Clearance details
- Applicant
- Lumenis, Ltd.
- Product code
- Product code ONG
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Binyamina, IL
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