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FDA 510(k)

孔雀美膚，快達陽光系列 1000HT/1600HT/2000CT/2000HT/3200

K 號：K152452 · 2016-05-19

申請人Medtek Lighting Corp D/B/A Peacock Tanning
決定日期2016-05-19
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

Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200 is the device name listed in this FDA 510(k) record. The listed applicant is Medtek Lighting Corp D/B/A Peacock Tanning. It received FDA 510(k) clearance on 2016-05-19 under 510(k) number K152452. 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 Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200?

Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200 is a medical device that received FDA 510(k) clearance on 2016-05-19. The listed applicant is Medtek Lighting Corp D/B/A Peacock Tanning. The 510(k) number is K152452.

When did Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200 receive FDA 510(k) clearance?

Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200 received FDA 510(k) clearance on 2016-05-19, under 510(k) number K152452.

Who is the listed applicant for Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200?

The FDA 510(k) record lists Medtek Lighting Corp D/B/A Peacock Tanning as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200?

The FDA product code for Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200 is LEJ.

相關臨床試驗

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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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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