FDA 510(k)

LaserCap300, LaserCap224, LaserCap120, LaserCap80

K-Number: K161875 · 2016-09-30

Decision Date2016-09-30

Product CodeOAP

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

LaserCap300, LaserCap224, LaserCap120, LaserCap80 is a medical device manufactured by Transdermal Cap, Inc.. It received FDA 510(k) clearance on 2016-09-30 under approval number K161875. 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 LaserCap300, LaserCap224, LaserCap120, LaserCap80?

LaserCap300, LaserCap224, LaserCap120, LaserCap80 is a medical device that received FDA 510(k) clearance on 2016-09-30. It is manufactured by Transdermal Cap, Inc.. The 510(k) number is K161875.

When was LaserCap300, LaserCap224, LaserCap120, LaserCap80 approved by the FDA?

LaserCap300, LaserCap224, LaserCap120, LaserCap80 received FDA 510(k) clearance on 2016-09-30, under approval number K161875.

What company makes LaserCap300, LaserCap224, LaserCap120, LaserCap80?

LaserCap300, LaserCap224, LaserCap120, LaserCap80 is manufactured by Transdermal Cap, Inc..

What is the FDA product code for LaserCap300, LaserCap224, LaserCap120, LaserCap80?

The FDA product code for LaserCap300, LaserCap224, LaserCap120, LaserCap80 is OAP.

Other Devices by Transdermal Cap, Inc.

K203826LaserCap Family of Lasers 300, 224, 120 & 80

Related Devices (Code: OAP)

K162994Capillus302, Capillus312, Capillus352Capillus, LLC 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.