FDA 510(k)

헤어맥스 레이저

K-번호: K180885 · 2018-06-20

결정일2018-06-20

제품 코드OAP

자문 위원회PM

결정Substantially Equivalent

기기 요약

HairMax Laser is the device name listed in this FDA 510(k) record. The listed applicant is Lexington International, LLC. It received FDA 510(k) clearance on 2018-06-20 under 510(k) number K180885. 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 HairMax Laser?

HairMax Laser is a medical device that received FDA 510(k) clearance on 2018-06-20. The listed applicant is Lexington International, LLC. The 510(k) number is K180885.

When did HairMax Laser receive FDA 510(k) clearance?

HairMax Laser received FDA 510(k) clearance on 2018-06-20, under 510(k) number K180885.

Who is the listed applicant for HairMax Laser?

The FDA 510(k) record lists Lexington International, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HairMax Laser?

The FDA product code for HairMax Laser is OAP.

관련 기기 (코드: OAP)

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관련 기기 (코드: OAP)

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