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FDA 510(k)

iRestore Professional 282

K-Number: K183417 · 2019-05-17

ApplicantFreedom Laser Therapy, Inc.
Decision Date2019-05-17
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

iRestore Professional 282 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 2019-05-17 under 510(k) 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. The listed applicant is Freedom Laser Therapy, Inc.. The 510(k) number is K183417.

When did iRestore Professional 282 receive FDA 510(k) clearance?

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

Who is the listed applicant for iRestore Professional 282?

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 iRestore Professional 282?

The FDA product code for iRestore Professional 282 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.

K222081ID-510 iRestore EliteK213094ID-500 iRestore Hair Growth SystemK151662iRestore

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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