FDA 510(k)

NutraStim Hair Laser Helmet

K-Number: K160728 · 2016-09-16

Decision Date2016-09-16

Product CodeOAP

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

NutraStim Hair Laser Helmet is a medical device manufactured by Nutra Luxe MD, LLC. It received FDA 510(k) clearance on 2016-09-16 under approval number K160728. 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 NutraStim Hair Laser Helmet?

NutraStim Hair Laser Helmet is a medical device that received FDA 510(k) clearance on 2016-09-16. It is manufactured by Nutra Luxe MD, LLC. The 510(k) number is K160728.

When was NutraStim Hair Laser Helmet approved by the FDA?

NutraStim Hair Laser Helmet received FDA 510(k) clearance on 2016-09-16, under approval number K160728.

What company makes NutraStim Hair Laser Helmet?

NutraStim Hair Laser Helmet is manufactured by Nutra Luxe MD, LLC.

What is the FDA product code for NutraStim Hair Laser Helmet?

The FDA product code for NutraStim Hair Laser Helmet is OAP.

Other Devices by Nutra Luxe MD, LLC

K162371Pulsaderm ACE-All Blue K161941Pulsaderm Acne Device K150826Nutra Face Lift Model PE8050

Related Devices (Code: OAP)

K162994Capillus302, Capillus312, Capillus352Capillus, LLC K161875LaserCap300, LaserCap224, LaserCap120, LaserCap80Transdermal Cap, Inc. K161046Laser Helmet LH40-EVOTheradome, Inc. K160285Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Capillus, LLC K152587DermaScalp Laser CapDermascalp, LLC K153618Capillus202Capillus, 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.