FDA 510(k)

Laser hair growth helmet

K-Number: K213025 · 2022-05-12

ApplicantKam Yuen Plastic Products , Ltd.

Decision Date2022-05-12

Product CodeOAP

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Laser hair growth helmet is a medical device manufactured by Kam Yuen Plastic Products , Ltd.. It received FDA 510(k) clearance on 2022-05-12 under approval number K213025. 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 Laser hair growth helmet?

Laser hair growth helmet is a medical device that received FDA 510(k) clearance on 2022-05-12. It is manufactured by Kam Yuen Plastic Products , Ltd.. The 510(k) number is K213025.

When was Laser hair growth helmet approved by the FDA?

Laser hair growth helmet received FDA 510(k) clearance on 2022-05-12, under approval number K213025.

What company makes Laser hair growth helmet?

Laser hair growth helmet is manufactured by Kam Yuen Plastic Products , Ltd..

What is the FDA product code for Laser hair growth helmet?

The FDA product code for Laser hair growth helmet is OAP.

Other Devices by Kam Yuen Plastic Products , Ltd.

K190820Aimanfun Lumea Comfort K212907Aimanfun Lumea Comfort, A-2789/A-3588 K213027Laser Hair Growth Comb K230107Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588

Related Devices (Code: OAP)

K162994Capillus302, Capillus312, Capillus352Capillus, LLC K161875LaserCap300, LaserCap224, LaserCap120, LaserCap80Transdermal Cap, Inc. K160728NutraStim Hair Laser HelmetNutra Luxe MD, LLC K161046Laser Helmet LH40-EVOTheradome, Inc. K160285Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Capillus, LLC K152587DermaScalp Laser CapDermascalp, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.