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510(k) K232153

Avéli by Revelle Aesthetics, Inc. — Product Code OUP

K232153 is an FDA 510(k) premarket notification submitted by Revelle Aesthetics, Inc. for the device "Avéli". The FDA issued a decision of Substantially Equivalent on August 18, 2023. 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. Revelle Aesthetics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2023
Date Received
July 19, 2023
Clearance Type
Special
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 Revelle Aesthetics, Inc.

  • K221336 — Avéli (August 5, 2022)

Other clearances for product code OUP

  • 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)
  • DEN110004 — CABOCHON SYSTEM (July 12, 2013)

FDA data resources