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FDA 510(k)

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

K-Number: K192585 · 2020-01-29

Decision Date2020-01-29
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: OAP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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