FDA 510(k)

Capillus302, Capillus312, Capillus352

K-Number: K162994 · 2016-11-18

Decision Date2016-11-18

Product CodeOAP

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Capillus302, Capillus312, Capillus352 is a medical device manufactured by Capillus, LLC. It received FDA 510(k) clearance on 2016-11-18 under approval number K162994. 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 Capillus302, Capillus312, Capillus352?

Capillus302, Capillus312, Capillus352 is a medical device that received FDA 510(k) clearance on 2016-11-18. It is manufactured by Capillus, LLC. The 510(k) number is K162994.

When was Capillus302, Capillus312, Capillus352 approved by the FDA?

Capillus302, Capillus312, Capillus352 received FDA 510(k) clearance on 2016-11-18, under approval number K162994.

What company makes Capillus302, Capillus312, Capillus352?

Capillus302, Capillus312, Capillus352 is manufactured by Capillus, LLC.

What is the FDA product code for Capillus302, Capillus312, Capillus352?

The FDA product code for Capillus302, Capillus312, Capillus352 is OAP.

Other Devices by Capillus, LLC

K160285Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202 K153618Capillus202 K163170Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352

Related Devices (Code: OAP)

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 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.