FDA 510(k)

Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup

K-번호: K181253 · 2018-08-10

신청자Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC

결정일2018-08-10

제품 코드OAP

자문 위원회PM

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC를 신청인으로 등재한 기타 기록

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