Home / 510(k) Clearances / K150505

510(k) K150505

Cellfina System by Ulthera, Inc. — Product Code OUP

K150505 is an FDA 510(k) premarket notification submitted by Ulthera, Inc. for the device "Cellfina System". The FDA issued a decision of Substantially Equivalent on July 29, 2015. 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
July 29, 2015
Date Received
February 25, 2015
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 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)
  • K153677 — The Cellfina System (February 25, 2016)
  • 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)
  • K153677 — The Cellfina System (February 25, 2016)
  • K134010 — CABOCHON SYSTEM (April 14, 2014)
  • DEN110004 — CABOCHON SYSTEM (July 12, 2013)

FDA data resources