FDA.reportPublic FDA data

Ultrasonic body contouring system

Definition
An assembly of devices intended for the transdermal application of ultrasonic energy to rupture targeted fat cells in areas where they tend to enlarge (e.g., hips, thighs, abdomen, buttocks), to reshape those areas for cosmetic purposes. The assembly typically consists of a mains electricity (AC-powered) ultrasonic energy generator with user controls/interface and an ultrasonic transducer used to transmit the energy to a target area to emulsify fat cells; it may include a video imaging system that takes into account real-time body movement to precisely position the transducer during treatment. The use of this system may serve as a noninvasive outpatient procedure alternative to liposuction.
GUDID devices
50
Last updated
2022-11-30 07:38:13

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07290110122317Accent Prime System 120V For Inc.ALMA LASERS LTD.12022-11-22
07290110122324Accent Prime UltraSpeed Applicator for Inc.ALMA LASERS LTD.12022-11-22
07290110122331Accent Prime MiniSpeed Applicator for Inc.ALMA LASERS LTD.12022-11-22
07290110122348Accent Prime Ultra Applicator for Inc.ALMA LASERS LTD.12022-11-22
00840763100001Ulthera System Control UnitUlthera, Inc.UC-1 Rev. A2016-09-07
00840763100018Ulthera System HandpieceUlthera, Inc.UH-2 Rev. A2017-05-23
00840763100155Ulthera System Control UnitUlthera, Inc.UC-1 Rev. B2016-09-07
00840763100162Ulthera System Control UnitUlthera, Inc.UC-1 Rev. C2016-09-07
00840763100179Ulthera System Control UnitUlthera, Inc.UC-1 Rev. D2016-09-07
00840763100186Ulthera System Control UnitUlthera, Inc.UC-1 Rev. E2016-09-07
00840763100193Ulthera System Control UnitUlthera, Inc.UC-1 Rev. F2016-09-07
00840763100209Ulthera System Control UnitUlthera, Inc.UC-1 Rev. G2016-09-07
00840763100216Ulthera System Control UnitUlthera, Inc.UC-1 Rev. H2016-09-07
00840763100223Ulthera System Control UnitUlthera, Inc.UC-1 Rev. I2016-09-07
00840763100230Ulthera System Control UnitUlthera, Inc.UC-1 Rev. J2016-09-07
00840763100247Ulthera System Control UnitUlthera, Inc.UC-1 Rev. K2016-09-07
00840763100254Ulthera System Control UnitUlthera, Inc.UC-1 Rev. L2016-09-07
00840763100261Ulthera System HandpieceUlthera, Inc.UH-2 Rev. B2017-05-23
00840763100278Ulthera System HandpieceUlthera, Inc.UH-2 Rev. C2016-09-06
00840763100285Ulthera System HandpieceUlthera, Inc.UH-2 Rev. D2016-09-06
00840763100292Ulthera System HandpieceUlthera, Inc.UH-2 Rev. E2016-09-06
00840763100308Ulthera System HandpieceUlthera, Inc.UH-2 Rev. F2016-12-14
00840763100421Ulthera System HandpieceUlthera, Inc.UH-2 Rev. G2016-12-14
00840763100438Ulthera System HandpieceUlthera, Inc.UH-2 Rev. H2016-12-14
00840763100476Ulthera SystemUlthera, Inc.UC-1 Rev 12017-05-23
00840763100483Ulthera System HandpieceUlthera, Inc.UH-2 Rev. 12017-05-23
00840763100490Ulthera System HandpieceUlthera, Inc.UH-2 Rev. I2016-12-14
00840763100506Ulthera System HandpieceUlthera, Inc.UH-2 Rev. J2016-12-14
00840763100902Ulthera System Control UnitUlthera, Inc.UC-1 Rev R2018-04-27
00840763100919Ulthera System HandpieceUlthera, Inc.UH-2 Rev N2018-04-27
17290110121683Accent systemALMA LASERS LTD.12019-03-08
17290110121690Mini Speed HPALMA LASERS LTD.12019-03-24
07290109950990UltraShape Power SystemSYNERON MEDICAL LTDFG71481US2016-09-21
07290109951157UltraShape systemSYNERON MEDICAL LTDFG71051US2016-09-21
07290109951171U-Sculpt Transducer SYNERON MEDICAL LTDFG71031US2016-09-22
07290109951782UltraShape systemSYNERON MEDICAL LTDFG71051USR2016-09-25
07290109951812VDF Transducer packedSYNERON MEDICAL LTDFG71071USR2016-09-25
07290109952062UltraShape Power systemSYNERON MEDICAL LTDFG714812016-09-25
07290109952147U-Sculpt Power Transducer, SYNERON MEDICAL LTDFG715312016-09-26
07290109952345VDF Transducer, Ultrashape SYNERON MEDICAL LTDFG71072US2016-09-26
07290109952451UltraShape System, Packaged for USSYNERON MEDICAL LTDFG71052US2017-01-17
07290109952741UltraShape Power System, PackagedSYNERON MEDICAL LTDFG71481CA2018-03-26
00816995020141LiposonixSOLTA MEDICALP006392-032016-09-23
00816995020158LiposonixSOLTA MEDICALP006530-042016-09-23
00816995020172LiposonixSOLTA MEDICALP006472-052016-09-23
00816995020189LiposonixSOLTA MEDICALP006373-052016-09-23
00816995020196LiposonixSOLTA MEDICALP006145-012016-09-23
00816995020202LiposonixSOLTA MEDICALP005875-022016-09-23
00816995020219LiposonixSOLTA MEDICALP005999-052016-09-23
00816995027027VASERSOLTA MEDICALP005999R2017-12-14