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FDA 510(k)

iRestore

K-Number: K151662 · 2016-01-06

ApplicantFreedom Laser Therapy, Inc.
Decision Date2016-01-06
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

iRestore is a medical device manufactured by Freedom Laser Therapy, Inc.. It received FDA 510(k) clearance on 2016-01-06 under approval number K151662. 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 iRestore?

iRestore is a medical device that received FDA 510(k) clearance on 2016-01-06. It is manufactured by Freedom Laser Therapy, Inc.. The 510(k) number is K151662.

When was iRestore approved by the FDA?

iRestore received FDA 510(k) clearance on 2016-01-06, under approval number K151662.

What company makes iRestore?

iRestore is manufactured by Freedom Laser Therapy, Inc..

What is the FDA product code for iRestore?

The FDA product code for iRestore is OAP.

Other Devices by Freedom Laser Therapy, Inc.

K183417iRestore Professional 282 K213094ID-500 iRestore Hair Growth System K222081ID-510 iRestore Elite

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

View on FDA Database →

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

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