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FDA 510(k)

PBM Hair Therapy Cap

K-Number: K240472 · 2024-10-11

Decision Date2024-10-11
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PBM Hair Therapy Cap is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Tutamen Metalwork Co., Ltd.. It received FDA 510(k) clearance on 2024-10-11 under 510(k) number K240472. 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 PBM Hair Therapy Cap?

PBM Hair Therapy Cap is a medical device that received FDA 510(k) clearance on 2024-10-11. The listed applicant is Dongguan Tutamen Metalwork Co., Ltd.. The 510(k) number is K240472.

When did PBM Hair Therapy Cap receive FDA 510(k) clearance?

PBM Hair Therapy Cap received FDA 510(k) clearance on 2024-10-11, under 510(k) number K240472.

Who is the listed applicant for PBM Hair Therapy Cap?

The FDA 510(k) record lists Dongguan Tutamen Metalwork Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PBM Hair Therapy Cap?

The FDA product code for PBM Hair Therapy Cap is OAP.

Other records listing Dongguan Tutamen Metalwork Co., Ltd. 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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