FDA 510(k)

HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux

Número K: K161394 · 2017-07-06

Data da decisão2017-07-06

Código do produtoLEJ

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux is the device name listed in this FDA 510(k) record. The listed applicant is Sportarredo Group S.C.. It received FDA 510(k) clearance on 2017-07-06 under 510(k) number K161394. The device is classified under product code LEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux?

HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux is a medical device that received FDA 510(k) clearance on 2017-07-06. The listed applicant is Sportarredo Group S.C.. The 510(k) number is K161394.

When did HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux receive FDA 510(k) clearance?

HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux received FDA 510(k) clearance on 2017-07-06, under 510(k) number K161394.

Who is the listed applicant for HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux?

The FDA 510(k) record lists Sportarredo Group S.C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux?

The FDA product code for HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux is LEJ.

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Outros registros que listam Sportarredo Group S.C. como candidato(a)

K152233BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux

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