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510(k) K153677

The Cellfina System by Ulthera, Inc. — Product Code OUP

K153677 is an FDA 510(k) premarket notification submitted by Ulthera, Inc. for the device "The Cellfina System". The FDA issued a decision of Substantially Equivalent on February 25, 2016. 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. Ulthera, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2016
Date Received
December 21, 2015
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 Ulthera, Inc.

  • K260618 — Ulthera® System (May 21, 2026)
  • K250418 — Ulthera System (UC-1 Control Unit PRIME Model 2.1) (May 13, 2025)
  • K243035 — Ulthera® System (February 24, 2025)
  • K233996 — Ulthera System (UC-1 Control Unit PRIME) (February 22, 2024)
  • K192185 — The Cellfina System (October 9, 2019)
  • K180623 — Ulthera System (May 4, 2018)
  • K161885 — The Cellfina System (October 5, 2016)
  • K150505 — Cellfina System (July 29, 2015)
  • K134032 — ULTHERA SYSTEM (June 20, 2014)
  • K132028 — ULTHERA SYSTEM (December 11, 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)
  • K150505 — Cellfina System (July 29, 2015)
  • K134010 — CABOCHON SYSTEM (April 14, 2014)
  • DEN110004 — CABOCHON SYSTEM (July 12, 2013)

FDA data resources