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510(k) K134010

CABOCHON SYSTEM by Cabochon Aesthetics, Inc. — Product Code OUP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2014
Date Received
December 30, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
Device Class
Class II
Regulation Number
878.4790
Review Panel
SU
Submission Type

Used for controlled release of subcutaneous tissue for improvement in the appearance of cellulite.

Other clearances by Cabochon Aesthetics, Inc.

  • DEN110004 — CABOCHON SYSTEM (July 12, 2013)

Other clearances for product code OUP

  • K232153 — Avéli (August 18, 2023)
  • K221336 — Avéli (August 5, 2022)
  • K212399 — Aveli (October 22, 2021)
  • K192185 — The Cellfina System (October 9, 2019)
  • K161885 — The Cellfina System (October 5, 2016)
  • K153677 — The Cellfina System (February 25, 2016)
  • K150505 — Cellfina System (July 29, 2015)
  • DEN110004 — CABOCHON SYSTEM (July 12, 2013)