FDA 510(k)

Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap

Numéro K : K192585 · 2020-01-29

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

Date de décision2020-01-29

Code produitOAP

Comité consultatifPM

DécisionSubstantially Equivalent

Résumé du dispositif

Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap 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 2020-01-29 under 510(k) number K192585. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap?

Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap is a medical device that received FDA 510(k) clearance on 2020-01-29. The listed applicant is Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC. The 510(k) number is K192585.

When did Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap receive FDA 510(k) clearance?

Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap received FDA 510(k) clearance on 2020-01-29, under 510(k) number K192585.

Who is the listed applicant for Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap?

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 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap?

The FDA product code for Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap is OAP.

Essais cliniques associés

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Dispositifs connexes (Code : OAP)

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Source officielle

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