FDA 510(k)

ID-510 iRestore Elite

K-Number: K222081 · 2022-10-13

Decision Date2022-10-13

Product CodeOAP

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

ID-510 iRestore Elite is a medical device manufactured by Freedom Laser Therapy, Inc.. It received FDA 510(k) clearance on 2022-10-13 under approval number K222081. 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 ID-510 iRestore Elite?

ID-510 iRestore Elite is a medical device that received FDA 510(k) clearance on 2022-10-13. It is manufactured by Freedom Laser Therapy, Inc.. The 510(k) number is K222081.

When was ID-510 iRestore Elite approved by the FDA?

ID-510 iRestore Elite received FDA 510(k) clearance on 2022-10-13, under approval number K222081.

What company makes ID-510 iRestore Elite?

ID-510 iRestore Elite is manufactured by Freedom Laser Therapy, Inc..

What is the FDA product code for ID-510 iRestore Elite?

The FDA product code for ID-510 iRestore Elite is OAP.

Other Devices by Freedom Laser Therapy, Inc.

K151662iRestore K183417iRestore Professional 282 K213094ID-500 iRestore Hair Growth System

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.