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510(k) K171992

SculpSure by Cynosure, Inc. — Product Code PKT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2017
Date Received
July 3, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Device Class
Class II
Regulation Number
878.5400
Review Panel
SU
Submission Type

Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.

Other clearances by Cynosure, Inc.

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  • K210226 — PicoSure Workstation (March 30, 2021)
  • K200241 — TempSure System (March 25, 2020)
  • K193426 — Elite iQ (March 9, 2020)
  • K190678 — TempSure (July 24, 2019)
  • K182741 — SculpSure (January 3, 2019)
  • K182365 — TempSure System (October 24, 2018)

Other clearances for product code PKT

  • K240658 — 1060nm laser body slimming machine (May 13, 2024)
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  • K231971 — DEKA PHYSIQ 360 (September 26, 2023)
  • K231131 — Diode Laser Body Sculpture Systems (June 22, 2023)
  • K222226 — EON (February 17, 2023)
  • K222265 — Diosculpt (September 23, 2022)
  • K211681 — EON (March 30, 2022)
  • K212331 — BodySculp (November 9, 2021)
  • K211402 — Powersculp laser lipolysis system (July 30, 2021)
  • K192970 — SLIMUS (December 1, 2020)