FDA 510(k)

BPhase、HPO 種類、LPI、LP2、LP3、Mastersun 360、Mastersun 360 新反光罩、Vega Lux

K 號：K152233 · 2016-01-27

決定日期2016-01-27

產品代碼LEJ

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 Sportarredo Group S.C. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K161394HPO 狂野，LP1，LP2，LP3，Mastersun 360，Mastersun 360 新反光罩，Vega Lux

相關器械（代碼：LEJ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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