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510(k) K210965

reVive Light Therapy Essentials by Led Technologies, Inc. — Product Code OHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2021
Date Received
March 31, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Based Over The Counter Wrinkle Reduction
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type

Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.

Other clearances by Led Technologies, Inc.

  • K223482 — reVive Light Therapy® Wrinkle and Acne LED Device (December 21, 2022)
  • K221430 — reVive Light Therapy LED Cleansing System (July 27, 2022)
  • K210968 — reVive Light Therapy Essentials (December 21, 2021)
  • K183247 — dpl Faceware (March 14, 2019)
  • K183118 — dpl SpotLite (February 7, 2019)
  • K180447 — reVive Light Therapy LED Cleansing System (June 4, 2018)
  • K180445 — reVive Light Therapy LED Ultrasonic Wrinkle System (May 15, 2018)
  • K180320 — dpl IIa Panel (April 3, 2018)
  • K172662 — reVive Perioral (January 9, 2018)
  • K171386 — dpl SpectraLite (August 7, 2017)

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  • K253833 — Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD0 (January 30, 2026)
  • K252603 — HIGHERDOSE Body Sculptor (Model: GS-03) (January 28, 2026)
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  • K253400 — LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X (December 24, 2025)
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  • K253135 — LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1 (December 23, 2025)
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