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FDA 510(k)

reVive Light Therapy Essentials

K-Number: K210965 · 2021-12-15

ApplicantLed Technologies, Inc.
Decision Date2021-12-15
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

reVive Light Therapy Essentials is a medical device manufactured by Led Technologies, Inc.. It received FDA 510(k) clearance on 2021-12-15 under approval number K210965. 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 Essentials?

reVive Light Therapy Essentials is a medical device that received FDA 510(k) clearance on 2021-12-15. It is manufactured by Led Technologies, Inc.. The 510(k) number is K210965.

When was reVive Light Therapy Essentials approved by the FDA?

reVive Light Therapy Essentials received FDA 510(k) clearance on 2021-12-15, under approval number K210965.

What company makes reVive Light Therapy Essentials?

reVive Light Therapy Essentials is manufactured by Led Technologies, Inc..

What is the FDA product code for reVive Light Therapy Essentials?

The FDA product code for reVive Light Therapy Essentials is OHS.

Related Clinical Trials

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Related PubMed Literature

PMID: 40417352 Regulatory aspects of optogenetic research and therapy for retinitis pigmentosa under EU law. Frontiers in medical technology (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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Related Devices (Code: OHS)

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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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