FDA.report

Phacoemulsification system

Definition
An assembly of ophthalmic devices intended to deliver energy (e.g., ultrasonic, piezoelectric) through a dedicated handpiece tip, which is introduced through an incision made in the lens capsule, to perform phacoemulsification (a procedure for the liquefaction and removal of the opaque lens nucleus in cataract surgery). The system will typically consist of a mains electricity (AC-powered) generator providing the energy, an irrigation and suction system for the removal of the debris, handpieces and cables, the tips/needles/electrodes, and a foot control.
GUDID devices
60
Last updated
2026-02-20 16:10:53

Related Product Codes

CodeDeviceSpecialtyClassDevices
HQCUnit, PhacofragmentationOphthalmic259
MLZVitrectomy, Instrument CutterOphthalmic21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
07640179410236SOPHI AThis AG1801-01002026-02-11
07640179410007SOPHIThis AG1401-0100-ACW2026-02-10
07640179410090SOPHIThis AG1401-0100-A2026-02-10
00380650002976UNITYAlcon Laboratories, Inc.003806500029762025-11-18
00380650005656CenturionAlcon Laboratories, Inc.80650005652024-07-25
00850005541042MICOR VitrectorCarl Zeiss Meditec, Cataract Technology, Inc.FG-508292023-07-28
00380657530571CenturionAlcon Laboratories, Inc.80657530572023-04-24
00850039020001Console, M2000, ValueMedical Technical Products, Inc.02-90222023-02-15
00850039020018Console, M2000, EnhancedMedical Technical Products, Inc.23-90232023-02-15
00850039020025Console, M2000, PremiumMedical Technical Products, Inc.02-90282023-02-15
00850039020056Console, M3000Medical Technical Products, Inc.551-0034-0012023-02-15
00850039020339Operators Manual, M3000Medical Technical Products, Inc.551-6001-0012023-02-14
00850039020346Service Manual, M3000Medical Technical Products, Inc.551-6008-0012023-02-14
00850039020353Operators Manual, M2000, ValueMedical Technical Products, Inc.75-90022023-02-14
00850039020360Operators Manual, M2000, Value, ChineseMedical Technical Products, Inc.75-9002CH2023-02-14
00850039020377Operators Manual, M2000, PremiumMedical Technical Products, Inc.75-90032023-02-14
00850039020384Operators Manual, M2000, Premium, ChineseMedical Technical Products, Inc.75-9003CH2023-02-14
05050474700857VERITAS REMOTE CONTROLJOHNSON & JOHNSON SURGICAL VISION, INC.VRT6801352021-04-16
05050474700864VERITAS VISION SYSTEMJOHNSON & JOHNSON SURGICAL VISION, INC.VRT6803002021-04-16
05050474700871VERITAS FOOTPEDALJOHNSON & JOHNSON SURGICAL VISION, INC.VRT6807002021-04-16
10860000122365MICOR extractorIANTECH, INC.FG-506212021-01-29
30860000122376MICOR driveIANTECH, INC.FG-506312021-01-29
05050474508088WHITESTAR PHACO HANDPIECEJOHNSON & JOHNSON SURGICAL VISION, INC.6907052016-09-09
05050474514683SOVEREIGN COMPACTJOHNSON & JOHNSON SURGICAL VISION, INC.CMP6800022018-01-22
05050474514690SOVEREIGN COMPACTJOHNSON & JOHNSON SURGICAL VISION, INC.CMP6801352018-01-22
05050474514706SOVEREIGN COMPACTJOHNSON & JOHNSON SURGICAL VISION, INC.CMP6803002018-01-22
05050474514713SOVEREIGN COMPACTJOHNSON & JOHNSON SURGICAL VISION, INC.CMP6807002018-01-22
05050474514751SOVEREIGN COMPACTJOHNSON & JOHNSON SURGICAL VISION, INC.CMP680P22018-01-22
05050474514782SOVEREIGN COMPACTJOHNSON & JOHNSON SURGICAL VISION, INC.CMPR6803002018-01-22
05050474523500UNIVERSAL IV POLE EXTENDERJOHNSON & JOHNSON SURGICAL VISION, INC.SOV1921812018-01-22
05050474530362SOVEREIGN COMPACTJOHNSON & JOHNSON SURGICAL VISION, INC.CMP6807202018-01-22
05050474534421WHITESTAR TECHNOLOGYJOHNSON & JOHNSON SURGICAL VISION, INC.CMPTUPU512018-01-22
05050474534476WHITESTAR SIGNATUREJOHNSON & JOHNSON SURGICAL VISION, INC.NGP6803002016-09-02
05050474534483WHITESTAR SIGNATUREJOHNSON & JOHNSON SURGICAL VISION, INC.NGP6807012018-01-22
05050474534575WHITESTAR PHACO HANDPIECEJOHNSON & JOHNSON SURGICAL VISION, INC.6908592016-09-09
05050474534599WHITESTAR SIGNATUREJOHNSON & JOHNSON SURGICAL VISION, INC.NGP680701R2018-01-22
05050474534636WHITESTAR SIGNATUREJOHNSON & JOHNSON SURGICAL VISION, INC.NGP680135R2016-09-02
05050474534667WHITESTAR SIGNATUREJOHNSON & JOHNSON SURGICAL VISION, INC.NGP6807022018-01-22
05050474540293ELLIPS FX PHACO HANDPIECEJOHNSON & JOHNSON SURGICAL VISION, INC.6908812016-09-09
05050474540330WHITESTAR SIGNATUREJOHNSON & JOHNSON SURGICAL VISION, INC.NGP680702R2018-01-22
05050474540347WHITESTAR TECHNOLOGYJOHNSON & JOHNSON SURGICAL VISION, INC.CMPTUPU522018-01-22
05050474547049WHITESTAR SIGNATUREJOHNSON & JOHNSON SURGICAL VISION, INC.NGP6801362018-01-22
05050474547735WHITESTAR SIGNATUREJOHNSON & JOHNSON SURGICAL VISION, INC.NGP680136R2018-01-22
05050474573581COMPACT INTUITIVJOHNSON & JOHNSON SURGICAL VISION, INC.SCP6800022018-01-22
05050474573598COMPACT INTUITIVJOHNSON & JOHNSON SURGICAL VISION, INC.SCP6800032018-01-22
05050474573604COMPACT INTUITIVJOHNSON & JOHNSON SURGICAL VISION, INC.SCP6800052018-01-22
05050474573611COMPACT INTUITIVJOHNSON & JOHNSON SURGICAL VISION, INC.SCP6801352018-01-22
05050474573628COMPACT INTUITIVJOHNSON & JOHNSON SURGICAL VISION, INC.SCP6803002018-01-22
05050474573642COMPACT INTUITIVJOHNSON & JOHNSON SURGICAL VISION, INC.SCP6807012018-01-22
05050474596115WHITESTAR SIGNATURE PROJOHNSON & JOHNSON SURGICAL VISION, INC.NGP6801372018-01-22
05050474596122WHITESTAR SIGNATURE PROJOHNSON & JOHNSON SURGICAL VISION, INC.NGP6807032018-01-22
05050474596146WHITESTAR SIGNATURE PROJOHNSON & JOHNSON SURGICAL VISION, INC.NGP6803012018-01-22
05050474609839SOVEREIGN COMPACTJOHNSON & JOHNSON SURGICAL VISION, INC.CMPR6807202018-01-22
05050474609846COMPACT INTUITIVJOHNSON & JOHNSON SURGICAL VISION, INC.SCP680701R2018-01-22
05050474611672WHITESTAR TECHNOLOGYJOHNSON & JOHNSON SURGICAL VISION, INC.CMPTUPU402018-01-22
05050474611689WHITESTAR TECHNOLOGYJOHNSON & JOHNSON SURGICAL VISION, INC.CMPTUPU502018-01-22
07630003909685Oertli®Oertli-Instrumente AGVV621010A2016-09-20
07630003910445Oertli®Oertli-Instrumente AGVC8211002016-09-19
07630003910452Oertli®Oertli-Instrumente AGVE8210152016-09-19
00380658036027AlconAlcon Laboratories, Inc.80658036022018-01-16