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OHV — Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption Class II

FDA Device Classification

Classification Details

Product Code
OHV
Device Class
Class II
Regulation Number
878.4590
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250418ultheraUlthera System (UC-1 Control Unit PRIME Model 2.1)May 13, 2025
K243035ultheraUlthera® SystemFebruary 24, 2025
K240687sofwave medicalSofWave SystemMay 30, 2024
K233996ultheraUlthera System (UC-1 Control Unit PRIME)February 22, 2024
K233104sofwave medicalSofWave SystemDecember 22, 2023
K232455sofwave medicalSofWave SystemDecember 14, 2023
K230100classysSCIZER (SC1-M410)November 3, 2023
K231628beshape technologiesBeShape One™ DeviceSeptember 29, 2023
K231537sofwave medicalSofWave SystemAugust 28, 2023
K230820sofwave medicalSofWave SystemApril 18, 2023
K230019sofwave medicalSofWave SystemMarch 14, 2023
K223237sofwave medicalSofWave SystemDecember 16, 2022
K211483sofwave medicalSofWave SystemNovember 15, 2021
K181896jeisys medicalLIPOcelOctober 18, 2019
K191421sofwave medicalSofacia SystemSeptember 9, 2019
K180623ultheraUlthera SystemMay 4, 2018
K170370syneron medicalULTRASHAPE POWER SYSTEMMay 15, 2017
K162163syneron medicalUltraShape SystemNovember 17, 2016
K161952syneron medicalUltraShape SystemNovember 7, 2016
K160896syneron medicalULTRASHAPE POWER SYSTEMJuly 8, 2016