BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux— 510(k) K152233
Substantially EquivalentSportarredo Group S.C.
FDA 510(k) clearance K152233 for BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux, Substantially Equivalent on 2016-01-27. 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
Recent devices under product code LEJ
view all- K221523 — Tanning Lamp
- K220500 — Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by Ergoline
- K191881 — KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun
- K190173 — Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound
- K183539 — Ergoline Sunrise 7200 Hybrid Technology
More clearances from Sportarredo Group S.C.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.