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510(k) K182741

SculpSure by Cynosure — Product Code PKT

K182741 is an FDA 510(k) premarket notification submitted by Cynosure for the device "SculpSure". The FDA issued a decision of Substantially Equivalent on January 3, 2019. The device falls under product code PKT (Laser For Disruption Of Adipocyte Cells For Aesthetic Use), a Class II device regulated under 21 CFR 878.5400. Cynosure has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2019
Date Received
September 28, 2018
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

  • K261570 — PICOSURE WORKSTATION (June 17, 2026)
  • K240396 — Elite iQ PRO (M122K1) (March 8, 2024)
  • K230510 — MyEllevate (July 6, 2023)
  • K223292 — TempSure System (November 23, 2022)
  • K212891 — TempSure System (March 18, 2022)
  • K210226 — PicoSure Workstation (March 30, 2021)
  • K200241 — TempSure System (March 25, 2020)
  • K193426 — Elite iQ (March 9, 2020)
  • K190678 — TempSure (July 24, 2019)
  • K182365 — TempSure System (October 24, 2018)

Other clearances for product code PKT

  • K240658 — 1060nm laser body slimming machine (May 13, 2024)
  • K233962 — ReBorn (1050nm) (April 16, 2024)
  • 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)

FDA data resources