HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux— 510(k) K161394
Substantially EquivalentSportarredo Group S.C.
FDA 510(k) clearance K161394 for HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux, Substantially Equivalent on 2017-07-06. Applicant: Sportarredo Group S.C.. Device class: 2.
Clearance details
- Applicant
- Sportarredo Group S.C.
- Product code
- Code LEJ
- Device class
- Class 2
- Regulation
- 21 CFR 878.4635
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gruaro, IT
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