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510(k) K243035

Ulthera® System by Ulthera, Inc. — Product Code OHV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2025
Date Received
September 27, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Device Class
Class II
Regulation Number
878.4590
Review Panel
SU
Submission Type

A device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for non-invasive aesthetic use.

Other clearances by Ulthera, Inc.

  • K250418 — Ulthera System (UC-1 Control Unit PRIME Model 2.1) (May 13, 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)
  • K150505 — Cellfina System (July 29, 2015)
  • K134032 — ULTHERA SYSTEM (June 20, 2014)
  • K132028 — ULTHERA SYSTEM (December 11, 2013)
  • K121700 — ULTHERA SYSTEM (October 2, 2012)

Other clearances for product code OHV

  • K250418 — Ulthera System (UC-1 Control Unit PRIME Model 2.1) (May 13, 2025)
  • K240687 — SofWave System (May 30, 2024)
  • K233996 — Ulthera System (UC-1 Control Unit PRIME) (February 22, 2024)
  • K233104 — SofWave System (December 22, 2023)
  • K232455 — SofWave System (December 14, 2023)
  • K230100 — SCIZER (SC1-M410) (November 3, 2023)
  • K231628 — BeShape One™ Device (September 29, 2023)
  • K231537 — SofWave System (August 28, 2023)
  • K230820 — SofWave System (April 18, 2023)
  • K230019 — SofWave System (March 14, 2023)