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510(k) K212399

Aveli by Nc8, Inc. — Product Code OUP

K212399 is an FDA 510(k) premarket notification submitted by Nc8, Inc. for the device "Aveli". The FDA issued a decision of Substantially Equivalent on October 22, 2021. 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2021
Date Received
August 2, 2021
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 for product code OUP

  • K232153 — Avéli (August 18, 2023)
  • K221336 — Avéli (August 5, 2022)
  • 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)
  • DEN110004 — CABOCHON SYSTEM (July 12, 2013)

FDA data resources