FDA 510(k)

Bosley Revitalizer 272 激光帽，Bosley Revitalizer 164 激光杯

K 號：K181253 · 2018-08-10

申請人Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC

決定日期2018-08-10

產品代碼OAP

諮詢委員會PM

決定相當於

器材摘要

Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup is the device name listed in this FDA 510(k) record. The listed applicant is Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC. It received FDA 510(k) clearance on 2018-08-10 under 510(k) number K181253. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup?

Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup is a medical device that received FDA 510(k) clearance on 2018-08-10. The listed applicant is Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC. The 510(k) number is K181253.

When did Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup receive FDA 510(k) clearance?

Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup received FDA 510(k) clearance on 2018-08-10, under 510(k) number K181253.

Who is the listed applicant for Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup?

The FDA 510(k) record lists Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup?

The FDA product code for Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup is OAP.

其他以 Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC 為申請人之記錄

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K192585Bosley Revitalizer 96 激光帽，Bosley Revitalizer 96 XL 激光帽

相關器械（代碼：OAP）

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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