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FDA 510(k)

ID-510 iRestore Elite

K-Number: K222081 · 2022-10-13

ApplicantFreedom Laser Therapy, Inc.
Decision Date2022-10-13
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ID-510 iRestore Elite is the device name listed in this FDA 510(k) record. The listed applicant is Freedom Laser Therapy, Inc.. It received FDA 510(k) clearance on 2022-10-13 under 510(k) 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. The listed applicant is Freedom Laser Therapy, Inc.. The 510(k) number is K222081.

When did ID-510 iRestore Elite receive FDA 510(k) clearance?

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

Who is the listed applicant for ID-510 iRestore Elite?

The FDA 510(k) record lists Freedom Laser Therapy, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Freedom Laser Therapy, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213094ID-500 iRestore Hair Growth SystemK183417iRestore Professional 282K151662iRestore

Related Devices (Code: OAP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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