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FDA 510(k)

reVive Light Therapy Essentials

K-Number: K210965 · 2021-12-15

Decision Date2021-12-15
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

reVive Light Therapy Essentials is the device name listed in this FDA 510(k) record. The listed applicant is Led Technologies, Inc.. It received FDA 510(k) clearance on 2021-12-15 under 510(k) 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. The listed applicant is Led Technologies, Inc.. The 510(k) number is K210965.

When did reVive Light Therapy Essentials receive FDA 510(k) clearance?

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

Who is the listed applicant for reVive Light Therapy Essentials?

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

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

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

Other records listing Led Technologies, 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.

View all 12 devices →

Related Devices (Code: OHS)

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.

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.