FDA 510(k)

Hair Laser Headband

K-Number: K182501 · 2018-10-26

Decision Date2018-10-26

Product CodeOAP

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Hair Laser Headband is a medical device manufactured by Pulsaderm, LLC. It received FDA 510(k) clearance on 2018-10-26 under approval number K182501. 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 Hair Laser Headband?

Hair Laser Headband is a medical device that received FDA 510(k) clearance on 2018-10-26. It is manufactured by Pulsaderm, LLC. The 510(k) number is K182501.

When was Hair Laser Headband approved by the FDA?

Hair Laser Headband received FDA 510(k) clearance on 2018-10-26, under approval number K182501.

What company makes Hair Laser Headband?

Hair Laser Headband is manufactured by Pulsaderm, LLC.

What is the FDA product code for Hair Laser Headband?

The FDA product code for Hair Laser Headband is OAP.

Other Devices by Pulsaderm, LLC

K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72

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.