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FDA 510(k)

ID-500 iRestore Hair Growth System

K-Number: K213094 · 2021-12-22

ApplicantFreedom Laser Therapy, Inc.
Decision Date2021-12-22
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ID-500 iRestore Hair Growth System is a medical device manufactured by Freedom Laser Therapy, Inc.. It received FDA 510(k) clearance on 2021-12-22 under approval number K213094. 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-500 iRestore Hair Growth System?

ID-500 iRestore Hair Growth System is a medical device that received FDA 510(k) clearance on 2021-12-22. It is manufactured by Freedom Laser Therapy, Inc.. The 510(k) number is K213094.

When was ID-500 iRestore Hair Growth System approved by the FDA?

ID-500 iRestore Hair Growth System received FDA 510(k) clearance on 2021-12-22, under approval number K213094.

What company makes ID-500 iRestore Hair Growth System?

ID-500 iRestore Hair Growth System is manufactured by Freedom Laser Therapy, Inc..

What is the FDA product code for ID-500 iRestore Hair Growth System?

The FDA product code for ID-500 iRestore Hair Growth System is OAP.

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Related PubMed Literature

PMID: 40258332 Chronic expanding hematoma following Gamma Knife irradiation for primary central nervous system lymphoma: illustrative case. Journal of neurosurgery. Case lessons (2025)

Other Devices by Freedom Laser Therapy, Inc.

K151662iRestore K183417iRestore Professional 282 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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