FDA 510(k)

Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap

Número K: K240456 · 2024-05-22

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

Data da decisão2024-05-22

Código do produtoOAP

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap is the device name listed in this FDA 510(k) record. The listed applicant is Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC. It received FDA 510(k) clearance on 2024-05-22 under 510(k) number K240456. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap?

Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap is a medical device that received FDA 510(k) clearance on 2024-05-22. The listed applicant is Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC. The 510(k) number is K240456.

When did Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap receive FDA 510(k) clearance?

Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap received FDA 510(k) clearance on 2024-05-22, under 510(k) number K240456.

Who is the listed applicant for Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap?

The FDA 510(k) record lists Plm 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 Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap?

The FDA product code for Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap is OAP.

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