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FDA 510(k)

reVive Light Therapy® Wrinkle and Acne LED Device

K-Number: K223482 · 2022-12-21

ApplicantLed Technologies, Inc.
Decision Date2022-12-21
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

reVive Light Therapy® Wrinkle and Acne LED Device is a medical device manufactured by Led Technologies, Inc.. It received FDA 510(k) clearance on 2022-12-21 under approval number K223482. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the reVive Light Therapy® Wrinkle and Acne LED Device?

reVive Light Therapy® Wrinkle and Acne LED Device is a medical device that received FDA 510(k) clearance on 2022-12-21. It is manufactured by Led Technologies, Inc.. The 510(k) number is K223482.

When was reVive Light Therapy® Wrinkle and Acne LED Device approved by the FDA?

reVive Light Therapy® Wrinkle and Acne LED Device received FDA 510(k) clearance on 2022-12-21, under approval number K223482.

What company makes reVive Light Therapy® Wrinkle and Acne LED Device?

reVive Light Therapy® Wrinkle and Acne LED Device is manufactured by Led Technologies, Inc..

What is the FDA product code for reVive Light Therapy® Wrinkle and Acne LED Device?

The FDA product code for reVive Light Therapy® Wrinkle and Acne LED Device is OHS.

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Related PubMed Literature

PMID: 41072144 Use of Bayesian decision analysis in the design of patient-centered clinical trials for kidney failure devices. Computers in biology and medicine (2025) PMID: 41040861 Enhancing post-operative hypothyroidism treatment: rat thyroid autotransplantation into a pre-vascularized, retrievable cell pouch™ device. Frontiers in endocrinology (2025) PMID: 40417352 Regulatory aspects of optogenetic research and therapy for retinitis pigmentosa under EU law. Frontiers in medical technology (2025) PMID: 40290478 Mental health apps in India: regulatory landscape and future directions. BJPsych international (2025)

Other Devices by Led Technologies, Inc.

K171386dpl SpectraLite K171390dpl II Panel K180447reVive Light Therapy LED Cleansing System K180445reVive Light Therapy LED Ultrasonic Wrinkle System K180320dpl IIa Panel K172662reVive Perioral

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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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