Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

Product Code: OHV

General & Plastic Surgery Ultrasonic Medical Devices (Miscellaneous)

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.

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 878.4590


Radiation TypeAcoustic
Radition SafetyNone
Annual ReportsNo

Products Classified as OHV

5801Focused Ultrasound For Tissue Heat Or Mechanical Cellular DisruptionFocused Ultrasound Stimulator System For Aesthetic Use.

Total Product Life Cycle (TPLC) Devices

5801Focused Ultrasound For Tissue Heat Or Mechanical Cellular DisruptionFocused Ultrasound Stimulator System For Aesthetic Use.

FDA Consensus Standards

Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption [32415]21 CFR §878.4590 🔎
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption [32395]21 CFR §878.4590 🔎

Pre-market Notifications for OHV

K191421Sofacia SystemSofwave Medical Ltd.
K181896LIPOcelJeisys Medical, Inc.
K180623Ulthera SystemUlthera, Inc
K170370ULTRASHAPE POWER SYSTEMSyneron Medical Ltd.
K162163UltraShape SystemSYNERON MEDICAL LTD
K161952UltraShape SystemSyneron Medical Ltd.
K160896ULTRASHAPE POWER SYSTEMSYNERON MEDICAL LTD
K141708ULTRASHAPE SYSTEMSYNERON MEDICAL LTD.
K134032ULTHERA SYSTEMULTHERA, INC.
K133238CONTOUR I V3.1 SYSTEMSYNERON MEDICAL LTD
K132028ULTHERA SYSTEMULTHERA, INC.
K122528ULTHERA SYSTEMULTHERA, INC.
K121700ULTHERA SYSTEMULTHERA, INC.
K112626LIPSONIX(R) SYSTEM MODEL 2MEDICIS TECHNOLOGIES CORPORATION
K100874LIPOSONIX SYSTEM, MODEL 1 P00XXXXMEDICIS TECHNOLOGIES CORPORATION

Global Unique Device Identification Database

00816995027027Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
00816995020219Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
00816995020202Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
00816995020196Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
00816995020189Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
00816995020172Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
00816995020158Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
00816995020141Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
07290109952741Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
07290109952451Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
07290109952345Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
07290109952147Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
07290109952062Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
07290109951812Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
07290109951782Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

Maude Adverse Events

ULTHERA SYSTEMULTHERA, INC., MERZ DEVICE INNOVATION CENTER2020-03-17
ULTHERA SYSTEMULTHERA, INC., MERZ DEVICE INNOVATION CENTER2020-01-30
ULTHERAPYMERZ NORTH AMERICA, INC.2020-01-27
ULTHERA SYSTEMULTHERA, INC., MERZ DEVICE INNOVATION CENTER2019-10-16
ULTHERA SYSTEMULTHERA, INC., MERZ DEVICE INNOVATION CENTER2019-08-28
ULTHERA SYSTEMULTHERA, INC., MERZ DEVICE INNOVATION CENTER2019-08-09
ULTHERA SYSTEMULTHERA, INC., MERZ DEVICE INNOVATION CENTER2019-07-26
ULTHERAPY; AKA ULTHERA SYSTEMULTHERA, INC.2019-07-15
ULTHERA SYSTEMULTHERA, INC., MERZ DEVICE INNOVATION CENTER2019-07-12
ULTHERAPYULTHERA, INC.2019-07-03
ULTHERAPYULTHERA INC / MERZ2019-06-18
ULTHERAPYUNK2019-06-05
ULTHERAPYMERZ NORTH AMERICA, INC.2019-06-04
ULTHERA SYSTEMULTHERA, INC., MERZ DEVICE INNOVATION CENTER2019-04-24
ULTHERAPY DEVICEMERZ NORTH AMERICA, INC.2019-03-21
ULTHERA SYSTEMULTHERA, INC., MERZ DEVICE INNOVATION CENTER2019-03-05
ULTHERA SYSTEMULTHERA, INC., MERZ DEVICE INNOVATION CENTER2018-11-23
ULTHERAPYMERZ NORTH AMERICA, INC.2018-11-05
ULTHERAPYMERZ NORTH AMERICA, INC.2018-09-25
ULTHERAPYMERZ NORTH AMERICA, INC.2018-08-21
ULTHERA SYSTEMULTHERA, INC., MERZ DEVICE INNOVATION CENTER2018-08-20
LIPOSONIX SYSTEM MODEL 2SOLTA MEDICAL, INC.2018-06-18
ULTRASHAPE POWERSYNERON MEDICAL LTD. YOKNEAM, ILLIT, ISRAEL2018-05-25
ULTRASHAPESYNERON MEDICAL LTD.2018-05-11
ULTHERA SYSTEMULTHERA, INC., MERZ DEVICE INNOVATION CENTER2018-05-10
ULTHERAPY SYSTEM,ULTHERA2018-02-06
ULTHERA SYSTEMULTHERA, INC., MERZ DEVICE INNOVATION CENTER2017-12-10
ULTHERA SYSTEMULTHERA INC., MERZ DEVICE INNOVATION CENTER2017-11-22
ULTHERA SYSTEMULTHERA, INC., MERZ DEVICE INNOVATION CENTER2017-11-22
ULTHERA SYSTEMULTHERA, INC., MERZ DEVICE INNOVATION CENTER2017-11-03
ULTHERA SYSTEMULTHERA, INC., MERZ DEVICE INNOVATION CENTER2017-11-01
LIPOSONIX SYSTEMSOLTA MEDICAL2017-10-26
ULTHERA SYSTEMULTHERA, INC., MERZ DEVICE INNOVATION CENTER2017-10-25
ULTHERA SYSTEMULTHERA, INC., MERZ DEVICE INNOVATION CENTER2017-10-18
ULTHERA SYSTEMULTHERA, INC., MERZ DEVICE INNOVATION CENTER2017-10-17
ULTHERA SYSTEMULTHERA, INC., MERZ DEVICE INNOVATION CENTER2017-10-03
ULTHERA SYSTEMULTHERA, INC., MERZ DEVICE INNOVATION CENTER2017-10-03
ULTHERA SYSTEMULTHERA, INC., MERZ DEVICE INNOVATION CENTER2017-10-03
ULTHERAMERZ2017-09-13
LIPOSONIX SYSTEM MODEL 2SOLTA MEDICAL INC.2017-08-25
ULTHERA SYSTEMULTHERA, INC., MERZ DEVICE INNOVATION CENTER2017-07-25
LIPOSONIX SYSTEM MODEL 2BAUSCH + LOMB2017-07-25
ULTHERAPYULTHERA, INC.2017-07-06
ULTHERA SYSTEMULTHERA, INC., MERZ DEVICE INNOVATION CENTER2017-06-29
ULTHERAPYULTHERA INC.2017-06-28
LIPOSONIX SYSTEM MODEL 2SOLTA MEDICAL INC.2017-06-22
LIPOSONIX SYSTEM MODEL 2SOLTA MEDICAL, INC.2017-06-22
ULTHERAULTHERA, INC. MERZ DEVICE INNOVATION CENTER2017-06-08
ULTHERAPYULTHERA INC.2017-05-27
ULTHERAULTHERA, INC.2017-03-23
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