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510(k) K212891

TempSure System by Cynosure, LLC — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2022
Date Received
September 10, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Cynosure, LLC

  • K240396 — Elite iQ PRO (M122K1) (March 8, 2024)
  • K230510 — MyEllevate (July 6, 2023)
  • K223292 — TempSure System (November 23, 2022)
  • 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)
  • K173199 — PicoSure Workstation (February 7, 2018)

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