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510(k) K221430

reVive Light Therapy LED Cleansing System by Led Technologies, Inc. — Product Code OHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2022
Date Received
May 17, 2022
Clearance Type
Special
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)
  • K210968 — reVive Light Therapy Essentials (December 21, 2021)
  • K210965 — reVive Light Therapy Essentials (December 15, 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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