CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2— 510(k) K091125
Substantially EquivalentVerilux
FDA 510(k) clearance K091125 for CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2, Substantially Equivalent on 2010-09-03. Applicant: Verilux. Device class: 2.
Clearance details
- Applicant
- Verilux
- Product code
- Code ONE
- 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
- South St. Paul, MN, US
Recent devices under product code ONE
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