FDA 510(k)

iRestore Professional 282

K-Number: K183417 · 2019-05-17

Decision Date2019-05-17

Product CodeOAP

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

iRestore Professional 282 is a medical device manufactured by Freedom Laser Therapy, Inc.. It received FDA 510(k) clearance on 2019-05-17 under approval number K183417. 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 Professional 282?

iRestore Professional 282 is a medical device that received FDA 510(k) clearance on 2019-05-17. It is manufactured by Freedom Laser Therapy, Inc.. The 510(k) number is K183417.

When was iRestore Professional 282 approved by the FDA?

iRestore Professional 282 received FDA 510(k) clearance on 2019-05-17, under approval number K183417.

What company makes iRestore Professional 282?

iRestore Professional 282 is manufactured by Freedom Laser Therapy, Inc..

What is the FDA product code for iRestore Professional 282?

The FDA product code for iRestore Professional 282 is OAP.

Other Devices by Freedom Laser Therapy, Inc.

K151662iRestore 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

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