FDA 510(k)

BPhase, HPO 이국적, LPI, LP2, LP3, Mastersun 360, Mastersun 360 새 반사镜, Vega Lux

K-번호: K152233 · 2016-01-27

결정일2016-01-27

제품 코드LEJ

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

BPhase, HPO Exotic, LPI, 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 2016-01-27 under 510(k) number K152233. The device is classified under product code LEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

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

BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux is a medical device that received FDA 510(k) clearance on 2016-01-27. The listed applicant is Sportarredo Group S.C.. The 510(k) number is K152233.

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

BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux received FDA 510(k) clearance on 2016-01-27, under 510(k) number K152233.

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

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

Sportarredo Group S.C.를 신청인으로 등재한 기타 기록

K161394HPO 엑스오틱, LP1, LP2, LP3, 마스터선 360, 마스터선 360 뉴 리플렉터, 베가 럭스

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