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510(k) DEN110004

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

DEN110004 is an FDA 510(k) premarket notification submitted by Cabochon Aesthetics, Inc. for the device "CABOCHON SYSTEM". The FDA issued a decision of De Novo Granted on July 12, 2013. The device falls under product code OUP (Powered Surgical Instrument For Improvement In The Appearance Of Cellulite), a Class II device regulated under 21 CFR 878.4790. Cabochon Aesthetics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
July 12, 2013
Date Received
October 31, 2011
Clearance Type
Post-NSE
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.

  • K134010 — CABOCHON SYSTEM (April 14, 2014)

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)
  • K134010 — CABOCHON SYSTEM (April 14, 2014)

FDA data resources