FDA.reportPublic FDA data

Ultrasonic surgical system generator

Definition
An electrically-powered component of an ultrasonic surgical system intended to generate a high frequency electrical current that is converted, typically within a handpiece, into an ultrasonic oscillation to fragment hard and/or soft tissue cells upon contact with a vibrating tip. It is used in a variety of surgical disciplines (e.g., arthroscopy, gynaecology, neurosurgery, dental/craniomaxillofacial reconstructive surgery); it is not dedicated to dental applications. It provides the controls and monitoring functions for the system during the procedure, and typically regulates energy to the system via a foot-switch; integrated suction/aspiration function may be included.
GUDID devices
125
Last updated
2026-09-04 23:09:46

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04953170306754Ultrasonic GeneratorOLYMPUS MEDICAL SYSTEMS CORP.USG-4002016-09-21
03609820577104ACTEONSATELEC05.001.4002025-01-17
06972603519248SMTPSMTP Medical Co., Ltd.XD880B2025-09-24
07649990202075SupraFuser GeneratorSurgical Fusion Technologies GmbHSupraFuser Generator2024-04-12
07649990202259Stopper S-PI-A1.6Surgical Fusion Technologies GmbHStopper S-PI-A1.62024-04-12
07649990202266Stopper S-PI-A2.3Surgical Fusion Technologies GmbHStopper S-PI-A2.32024-04-12
07649990202273Stopper S-PI-A3.0Surgical Fusion Technologies GmbHStopper S-PI-A3.02024-04-12
07649990202303Sonotrode S-PISurgical Fusion Technologies GmbHSonotrode S-PI2024-04-12
07649990202181Handpiece Front CoverSurgical Fusion Technologies GmbHHandpiece Front Cover2024-01-10
07649990202204SupraFuser B GeneratorSurgical Fusion Technologies GmbHSupraFuser B Generator2024-02-06
07649990202082Handpiece SupraFuserSurgical Fusion Technologies GmbHHandpiece2024-02-05
07649990202037Sonotrode PI-S 2.3Surgical Fusion Technologies GmbHSonotrode PI-S 2.32023-12-14
07649990202051Wrench 5.0Surgical Fusion Technologies GmbHWrench 5.02023-12-14
07649990202143HandpieceSurgical Fusion Technologies GmbHHandpiece 2023-12-14
07649990202150BoneWelder 150-W1Surgical Fusion Technologies GmbHBoneWelder 150-W12023-12-14
06972603519002SMTPSMTP Medical Co., Ltd.XD880A2023-08-15
04250321532612SONOCA 185Söring GmbHS185-000B-FL2023-06-12
00816995021599POWERXSOLTA MEDICAL115-00302022-04-06
00816995021605POWERXSOLTA MEDICAL115-00312022-04-06
00816995026266VASERSOLTA MEDICAL130-00952022-04-06
00816995026273VASERSOLTA MEDICAL130-00972022-04-06
00816995026327VASERSOLTA MEDICAL130-01182022-04-06
00816995026334VASERSOLTA MEDICAL130-01192022-04-06
00816995021537VASERSOLTA MEDICAL115-00202022-04-05
00850608002575POWERXSOLTA MEDICAL115-00182022-04-05
00850608002582VASERSOLTA MEDICAL115-00192022-04-05
00816995026235VASERSOLTA MEDICAL115-00042022-03-31
07613327364675Sonopet iQSTRYKER CORPORATION55000500002019-05-07
00841626100930SonicOne O.R. MISONIX, INC.E-SOGEN-OR2016-09-24
00841626100985SonicOne ClinicMISONIX, INC.E-SOP-GEN2016-09-24
00841626101517SonaStarMISONIX, INC.SYSTEM-M200-0 2016-10-26
00841626101524SonaStarMISONIX, INC.SYSTEM-M200-0 (rev Ax)2016-09-24
00841626101531SonaStarMISONIX, INC.SYSTEM-M200-12016-10-26
00841626101548SonaStarMISONIX, INC.SYSTEM-M200-1 (rev Ax)2016-09-24
00841626101555SonaStarMISONIX, INC.SYSTEM-M200-22016-10-26
00841626101562SonaStarMISONIX, INC.SYSTEM-M200-2 (rev Ax)2016-09-24
00841626101579SonaStarMISONIX, INC.SYSTEM-M200-32016-10-26
00841626101586SonaStarMISONIX, INC.SYSTEM-M200-3 (rev Ax)2016-09-24
00841626101593SonaStar MISONIX, INC.SYSTEM-M260-0 (Rev L or higher)2016-09-24
00841626101609SonaStarMISONIX, INC.SYSTEM-M260-0 (Rev Kx)2016-09-24
00841626101616SonaStarMISONIX, INC.SYSTEM-M260-1 (Rev L or higher)2016-09-24
00841626101623SonaStar MISONIX, INC.SYSTEM-M260-1 (Rev Kx)2016-09-24
00841626101630SonaStarMISONIX, INC.SYSTEM-M260-2(Rev L or higher)2016-09-24
00841626101647SonaStarMISONIX, INC.SYSTEM-M260-2 (Rev Kx)2016-09-24
00841626101654SonaStarMISONIX, INC.SYSTEM-M260-3 (Rev L or higher)2016-09-24
00841626101661SonaStarMISONIX, INC.SYSTEM-M260-3 (rev Kx)2016-09-24
00841626101685SonaStarMISONIX, INC.SYSTEM-M280-0 (rev Jx)2016-09-24
00841626101708SonaStarMISONIX, INC.SYSTEM-M280-1 (rev Jx)2016-09-24
00841626101722SonaStarMISONIX, INC.SYSTEM-M280-2 (rev Jx)2016-09-24
00841626101746SonaStarMISONIX, INC.SYSTEM-M280-3 (rev Jx)2016-09-24
00841626101753SonaStarMISONIX, INC.SYSTEM-M300-02016-09-24
00841626101760SonaStar MISONIX, INC.SYSTEM-M300-12016-09-24
00841626101777SonaStarMISONIX, INC.SYSTEM-M300-22016-09-24
00841626101784SonaStarMISONIX, INC.SYSTEM-M300-32016-09-24
00841626101791SonaStarMISONIX, INC.SYSTEM-M360-02016-09-24
00841626101807SonaStarMISONIX, INC.SYSTEM-M360-12016-09-24
00841626101814SonaStar MISONIX, INC.SYSTEM-M360-22016-09-24
00841626101821SonaStarMISONIX, INC.SYSTEM-M360-32016-09-24
00841626101838SonaStarMISONIX, INC.SYSTEM-M380-02016-09-24
00841626101845SonaStarMISONIX, INC.SYSTEM-M380-12016-09-24
00841626101852SonaStarMISONIX, INC.SYSTEM-M380-22016-09-24
00841626101869SonaStar MISONIX, INC.SYSTEM-M380-32016-09-24
00841626102453neXusMISONIX, INC.100-10-00002020-02-24
00816995021520VASERSOLTA MEDICAL115-00092019-11-08
07613327298697Sonopet iQSTRYKER CORPORATION55004020002019-05-01
04250321532667SONOCA 300Söring GmbH15-000B-FL2016-09-17
14953170306744Ultrasonic GeneratorOLYMPUS MEDICAL SYSTEMS CORP.USG-4002016-09-21
14953170306751Ultrasonic GeneratorOLYMPUS MEDICAL SYSTEMS CORP.USG-4002016-09-21
04953170386817Ultrasonic GeneratorOLYMPUS MEDICAL SYSTEMS CORP.USG-4002017-11-28
07613327291872SonopetSTRYKER MEDTECH K.K.54508500002018-09-24
00850608002483VASERSOLTA MEDICAL110-00212016-09-23
00850608002506VASERSOLTA MEDICAL110-00322016-09-23
00850608002513VASERSOLTA MEDICAL110-00352016-09-23
00850608002537VASERSOLTA MEDICAL110-00372016-09-23
00850608002551VASERSOLTA MEDICALVHP2016-09-23
00850608002629VASERSOLTA MEDICALSHP2016-09-23
00850608002780VASERSOLTA MEDICAL130-01162016-09-23
00850608002797VASERSOLTA MEDICAL130-01272016-09-23
00850608002803VASERSOLTA MEDICAL130-01102016-09-23
00850608002810VASERSOLTA MEDICAL130-01172016-09-23