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Miscellaneous
OGO
Intraocular Pressure Lowering Implant
3
Product Code
QQU
Digital Therapy Device For Amblyopia
2
Product Code
HPX
Lens, Contact (Polymethylmethacrylate)
U
Product Code
LOG
Catheter, Balloon For Retinal Reattachment
3
Product Code
LOH
System, Identification, Contact Lens
3
Product Code
LOI
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
3
Product Code
LQB
Medical Computers And Software For Ophthalmic Use
3
Product Code
LQE
Implant, Corneal, Refractive
3
Product Code
LXQ
Cup, Eye
U
Product Code
LYX
Media, Corneal Storage
U
Product Code
LZQ
Tissue Adhesive For Ophthalmic Use
3
Product Code
LZR
Ultrasound, Cyclodestructive
3
Product Code
LZS
Excimer Laser System
3
Product Code
P
06
0004
MEL 80 EXCIMER LASER SYSTEM
APPR
PMA Approval
P
03
0008
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
APPR
PMA Approval
P
02
0050
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
APPR
PMA Approval
P
99
0027
TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z)
APPR
PMA Approval
P
99
0010
VISX EXCIMER LASER SYSTEM MODEL C STAR
APPR
PMA Approval
P
98
0008
LASERSCAN LSX EXCIMER LASER SYSTEM
APPR
PMA Approval
P
97
0056
BAUSCH & LOMB KERACOR 116 EXCIMER LASER SYSTEM
APWD
PMA Approval
P
97
0053
EC-5000 EXCIMER LASER SYSTEM
APPR
PMA Approval
P
97
0043
LADARVISION EXCIMER LASER SYSTEM
APWD
PMA Approval
P
97
0005
KREMER LASER SYSTEM
APPR
PMA Approval
P
03
0008
WaveLight EX500 Laser
3
PMA Approval
P
93
0016
iDESIGN Refractive Studio
3
PMA Approval
P
93
0016
iDESIGN Refractive Studio
3
PMA Approval
P
03
0008
WaveLight EX500 Laser System/Allegro Topolyzer Vario
3
PMA Approval
P
02
0050
WaveLight EX500 Laser System/Allegro Topolyzer Vario
3
PMA Approval
P
03
0008
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
3
PMA Approval
P
02
0050
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
3
PMA Approval
P
93
0016
STAR S4 IR Excimer Laser System and iDESIGN Refractive Studio
3
PMA Approval
P
93
0016
iDESIGN Refractive Studio and STAR S4 IR Excimer Laser Systems
3
PMA Approval
P
93
0016
iDESIGN Refractive Studio
3
PMA Approval
P
91
0062
STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System
3
PMA Approval
P
93
0016
STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System
3
PMA Approval
P
99
0010
STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System
3
PMA Approval
P
03
0008
WaveLight Analyzer II, ALLEGRO Topolyzer VARIO, Patient Bed Swivel
3
PMA Approval
P
02
0050
ALLEGRO Topolyzer VARIO and Patient Bed Swivel
3
PMA Approval
P
93
0016
iDESIGN Refractive Studio; STAR Excimer Laser System
3
PMA Approval
P
02
0050
WaveLight EX500 Excimer Laser System
3
PMA Approval
P
03
0008
WaveLight EX500 Excimer Laser System
3
PMA Approval
P
02
0050
WaveLight EX500 Laser System with Patient Bed Swivel 1125
3
PMA Approval
P
03
0008
WaveLight EX500 Laser System with Patient Bed Swivel 1125
3
PMA Approval
P
93
0016
iDESIGNRefractive Studio, STAR Excimer Laser System
3
PMA Approval
P
02
0050
WaveLight EX500 Laser System
3
PMA Approval
P
03
0008
WaveNet Planning Software
3
PMA Approval
P
02
0050
Wave Light EX500 Laser
3
PMA Approval
P
03
0008
Wave Light EX500 Laser
3
PMA Approval
P
93
0016
STAR Excimer Laser System
3
PMA Approval
P
97
0053
Nidek EC-5000 Excimer Laser System
3
PMA Approval
P
03
0008
WaveLight EX500 Laser System
3
PMA Approval
P
02
0050
WaveLight EX500 Laser System
3
PMA Approval
P
93
0016
Star S4 IR Excimer Laser System
3
PMA Approval
P
93
0016
STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System
3
PMA Approval
P
93
0016
Star S4 IR Excimer Laser System
3
PMA Approval
P
97
0053
EC-5000 EXCIMER LASER SYSTEM
3
PMA Approval
P
02
0050
Allegro Topolyzer Vario
3
PMA Approval
P
03
0008
Allegro Topolyzer Vario
3
PMA Approval
P
93
0016
iDesign Advanced WaveScan Studio
3
PMA Approval
P
93
0016
STAR EXCIMER LASER SYSTEM
3
PMA Approval
P
02
0050
WAVELIGHT EX500 EXCIMER LASER SYSTEM, ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
3
PMA Approval
P
93
0016
IDESIGN ADVANCED WAVESCAN STUDIO, STAR EXCIMER LASER SYSTEM
3
PMA Approval
P
93
0016
STAR EXCIMER LASER SYSTEM
3
PMA Approval
P
93
0016
STAR EXCIMER LASER SYSTEM
3
PMA Approval
P
99
0027
TECHNOLAS 217A EXCIMER LASER SYSTEM FOR LASER IN-SITU KERATOMILEUSIS(LASIK), TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALI
3
PMA Approval
P
02
0050
ALLEGRETTO WAVE EYE-Q
3
PMA Approval
P
03
0008
WAVELIGHT EX500 LASER SYSTEM
3
PMA Approval
P
02
0050
WAVELIGHT EX500 LASER SYSTEM
3
PMA Approval
P
93
0016
STAR S4 IR EXCIMER LASER SYSTEM WITH IDESIGN WAVESCAN STUDIO SYSTEM
3
PMA Approval
P
03
0008
WAVELIGHT EX500 LASER SYSTEM
3
PMA Approval
P
02
0050
WAVELIGHT EX500 LASER SYSTEM
3
PMA Approval
P
02
0050
ALLEGRO TOPOLYZER VARIO
3
PMA Approval
P
03
0008
ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
3
PMA Approval
P
03
0008
WAVELIGHT EX500 EXCIMER LASER SYSTEM
3
PMA Approval
P
02
0050
WAVELIGHT EX500 EXCIMER LASER SYSTEM
3
PMA Approval
P
97
0053
NIDEK EXCLAIMER LASER SYSTEM EC-5000
3
PMA Approval
P
02
0050
WAVELIGHT EX500 LASER SYSTEM
3
PMA Approval
P
03
0008
WAVELIGHT EX500 LASER SYSTEM
3
PMA Approval
P
02
0050
WAVE LIGHT EX500 LASER SYSTEM
3
PMA Approval
P
03
0008
WAVE LIGHT EX500 LASER SYSTEM
3
PMA Approval
P
97
0053
NIDEK EXCIMER LASER SYSTEM EC-5000
3
PMA Approval
P
97
0053
NIDEK EXCIMER LASER SYSTEM EC-5000
3
PMA Approval
P
93
0016
STAR EXCIMER LASER SYSTEM
3
PMA Approval
P
91
0062
STAR EXCIMER LASER SYSTEM
3
PMA Approval
P
99
0010
STAR EXCIMER LASER SYSTEM
3
PMA Approval
P
99
0010
STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO
3
PMA Approval
P
91
0062
STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO
3
PMA Approval
P
93
0016
STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO
3
PMA Approval
P
99
0010
STAR, S41R EXCIMER LASER SYSTEM
3
PMA Approval
P
91
0062
STAR S4 IM EXCIMER LASER SYSTEM
3
PMA Approval
P
93
0016
WAVESCAN WAVEFRONT SYSTEM
3
PMA Approval
P
02
0050
WAVELIGHT EX500 EXCIMER LASER SYSTEM
3
PMA Approval
P
03
0008
WAVELIGHT EX500 EXCIMER LASER SYSTEM
3
PMA Approval
P
99
0027
TECHNOLAS 217A EXCIMER LASER AND TEHNOLAS 217Z ZYOPTIX SYSTEMS
3
PMA Approval
P
03
0008
WAVELIGHT EX500 LASER SYSTEM
3
PMA Approval
P
02
0050
WAVELIGHT EX500 LASER SYSTEM
3
PMA Approval
P
02
0050
WAVELIGHT EX500 EXCIMER LASER SYSTEM
3
PMA Approval
P
03
0008
WAVELIGHT EX500 EXCIMER LASER SYSTEM
3
PMA Approval
P
02
0050
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
3
PMA Approval
P
03
0008
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
3
PMA Approval
P
97
0053
NIDEK 2000 EC-5000 EXCIMER LASER SYSTEM
3
PMA Approval
P
02
0050
ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
3
PMA Approval
P
93
0016
WAVESCAN WAVEFRONT SYSTEM
3
PMA Approval
P
99
0027
TECHNOLAS PERFECT VISION 217Z ZYOPTIX SYSTEM
3
PMA Approval
P
03
0008
WAVELIGHT LASER SYSTEM
3
PMA Approval
P
02
0050
WAVELIGHT EX500 EXCIMER LASER SYSTEM
3
PMA Approval
P
03
0008
WAVELIGHT EX 500 LASER SYSTEM
3
PMA Approval
P
02
0050
WAVELIGHT EX500 LASER SYSTEM, ALLEGRO ANALYZER
3
PMA Approval
P
02
0050
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
3
PMA Approval
P
99
0027
TECHNOLAS 217A EXCIMER LASER SYSTEM AND TECHNOLAS 217Z ZYOPTIX SYSTEM
3
PMA Approval
P
97
0053
NIDEK EC-5000 EXCIMER LASER SYSTEM
3
PMA Approval
P
02
0050
ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
3
PMA Approval
P
03
0008
ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
3
PMA Approval
P
93
0016
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)
3
PMA Approval
P
03
0008
ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEMS
3
PMA Approval
P
02
0050
ALLEGRETTO WAVE EXCIMER LASER SYSTEMS
3
PMA Approval
P
02
0050
WAVELIGHT EX500 LASER SYSTEM
3
PMA Approval
P
03
0008
WAVELIGHT EX500 LASER SYSTEM
3
PMA Approval
P
93
0016
STAR EXCIMER LASER & WAVESCAN WAVEFRONT SYSTEM
3
PMA Approval
P
06
0004
MEDITEC MEL 80 EXCIMER LASER SYSTEM
3
PMA Approval
P
93
0016
WAVESCAN WAVEFRONT SYSTEM SOFTWARE VERSION 3.68
3
PMA Approval
P
99
0027
TECHNOLAS 217Z ZYOPTIX SYSTEM
3
PMA Approval
P
99
0027
TECHNOLAS PERFECT VISION 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION
3
PMA Approval
P
99
0027
BAUSCH & LOMB TECHNOLAS T217Z ZYOPTIX LASER SYSTEM
3
PMA Approval
P
93
0016
STAR S4 & STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)
3
PMA Approval
P
99
0027
TECHNOLAS 217A EXCIMER LASER SYSTEM
3
PMA Approval
P
99
0027
BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION
3
PMA Approval
P
99
0027
BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX LASER SYSTEM
3
PMA Approval
P
93
0016
VISX STAR S4 IR EXCIMER LASER SYSTEM
3
PMA Approval
P
93
0016
STAT S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM
3
PMA Approval
P
93
0016
STAT S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM
3
PMA Approval
P
06
0004
MEL 80 EXCIMER LASER SYSTEM
3
PMA Approval
P
99
0027
BAUSCH& LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM
3
PMA Approval
P
93
0016
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) WAVESCAN WAVEFRONT SYSTEM
3
PMA Approval
P
93
0016
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)
3
PMA Approval
P
93
0016
STAR S4 IR EXCIMER LASER SYSTEM & WAVESCAN SYSTEM
3
PMA Approval
P
03
0008
WAVELIGHT ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
3
PMA Approval
P
02
0050
WAVELIGHT ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
3
PMA Approval
P
97
0053
NIDEK EC-5000 EXCIMER LASER
3
PMA Approval
P
93
0016
VISX STAR S4 IR EXCIMER LASER SYSTEM AND WAVESCAN SYSTEM
3
PMA Approval
P
97
0043
LADARVISION 4000 AND LADAR6000 EXCIMER LASER SYSTEMS AND THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE
3
PMA Approval
P
97
0053
NIDEK EC-5000 EXCIMER LASER SYSTEM
3
PMA Approval
P
06
0004
MEL 80 EXCIMER LASER SYSTEM
3
PMA Approval
P
02
0050
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
3
PMA Approval
P
97
0043
LADARVISION 4000 EXCIMER LASER SYSTEM AND THE LADAR 6000 EXCIMER LASER SYSTEM
3
PMA Approval
P
02
0050
ALLEGRETTO WAVE EYE-Q LASER SYSTEM
3
PMA Approval
P
03
0008
ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
3
PMA Approval
P
93
0016
VISX STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM
3
PMA Approval
P
97
0043
LADARVISION 4000 EXCIMER LASER SYSTEM AND THE LADAR 6000 EXCIMER LASER SYSTEM
3
PMA Approval
P
97
0043
LADAR 6000 EXCIMER LASER SYSTEM
3
PMA Approval
P
97
0043
LADARVISION 4000 EXCIMER LASER SYSTEM
3
PMA Approval
P
97
0043
LADAR 6000 EXCIMER LASER SYSTEM
3
PMA Approval
P
03
0008
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
3
PMA Approval
P
99
0027
BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION
3
PMA Approval
P
97
0043
ALCON LADARVISION 4000 EXCIMER LASER SYSTEM-
3
PMA Approval
P
93
0016
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM
3
PMA Approval
P
93
0016
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM
3
PMA Approval
P
93
0016
STAR S4 IR EXCIMER LASER SOFTWARE, VERSION 5.10
3
PMA Approval
P
93
0016
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)
3
PMA Approval
P
93
0016
STAR S4 EXCIMER LASER AND WAVESCAN WAVEFRONT SYSTEMS
3
PMA Approval
P
02
0050
ALLEGRETTO WAVE EXCIMER LASER SYSTEM
3
PMA Approval
P
03
0008
ALLEGRETTO WAVE EXCIMER LASER SYSTEMS
3
PMA Approval
P
93
0016
STAR S4 EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM
3
PMA Approval
P
97
0043
LADARVISION 4000 EXCIMER LASER SYSTEM
3
PMA Approval
P
93
0016
STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM
3
PMA Approval
P
03
0008
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
3
PMA Approval
P
02
0050
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
3
PMA Approval
P
97
0053
NIDEK EC-5000 EXCIMER LASER SYSTEM
3
PMA Approval
P
97
0043
LADAR VISION 4000 EXCIMER LASER SYSTEM
3
PMA Approval
P
97
0043
LADARVISION 4000 EXCIMER LASER SYSTEM
3
PMA Approval
P
03
0008
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
3
PMA Approval
P
99
0027
BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION
3
PMA Approval
P
02
0050
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
3
PMA Approval
P
97
0043
LADARVISION 4000 EXCIMER LASER SYSTEM
3
PMA Approval
P
97
0043
LADARVISION 4000 EXCIMER LASER SYSTEM
3
PMA Approval
P
93
0016
STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM
3
PMA Approval
P
99
0027
TECHNOLAS 217A EXCIMER LASER SYSTEM
3
PMA Approval
P
98
0008
LSX EXCIMER LASER SYSTEM
3
PMA Approval
P
97
0043
LADARVISION 4000 EXCIMER LASER SYSTEM
3
PMA Approval
P
97
0053
NIDEK EC-5000 EXCIMER LASER SYSTEM
3
PMA Approval
P
97
0043
LADARVISION 4000 EXCIMER LASER SYSTEM
3
PMA Approval
P
93
0016
VISX STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM
3
PMA Approval
P
99
0027
TECHNOLAS 217A EXCIMER LASER SYSTEM
3
PMA Approval
P
99
0027
TECHNOLAS 217A EXCIMER LASER SYSTEM
3
PMA Approval
P
98
0008
LASERSCAN LSX EXCIMER LASER SYSTEM
3
PMA Approval
P
93
0016
VISX STAR EXCIMER LASER SYSTEM
3
PMA Approval
P
98
0008
LASERSCAN LSX EXCIMER LASER SYSTEM
3
PMA Approval
P
98
0008
LASERSIGHT LASERSCAN LSX EXCIMER LASER SYSTEM FOR LASER-ASSITED IN SITU KERATOMILEUSIS (LASIK)
3
PMA Approval
P
99
0027
TECHNOLAS(R)217A OPHTHALMIC EXCIMER LASER SYSTEM
3
PMA Approval
P
97
0053
NIDEK EC-5000 EXCIMER LASER SYSTEM
3
PMA Approval
P
93
0016
VISX STAR EXCIMER LASER SYSTEM
3
PMA Approval
P
93
0016
VISX STAR S2/S3 EXCIMER LASER SYSTEM
3
PMA Approval
P
97
0053
NIDEK EC-5000 EXCIMER LASER SYSTEM
3
PMA Approval
P
99
0027
TECHNOLAS 217A EXCIMER LASER SYSTEM
3
PMA Approval
P
98
0008
LASERSCAN LSX EXCIMER LASER
3
PMA Approval
P
97
0053
EC-5000 EXCIMER LASER SYSTEM
3
PMA Approval
P
93
0016
VISX STAR S2 AND S3 EXCIMER LASER SYSTEM
3
PMA Approval
P
97
0043
LADAR VISION EXCIMER LASER SYSTEM (HYPEROPIA)
3
PMA Approval
P
97
0043
LADARVISION EXCIMER LASER SYSTEM
3
PMA Approval
P
98
0008
LASER SCAN LSX EXCIMER LASER
3
PMA Approval
P
97
0043
SUMMIT AUTONOMOUS LADARVISION 4000 SYSTEM
3
PMA Approval
P
97
0043
LADARVISION EXCIMER LASER SYSTEM
3
PMA Approval
P
91
0062
VISX STAR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER)
3
PMA Approval
P
93
0016
VISX STARR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER)
3
PMA Approval
P
99
0010
VISX STAR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER)
3
PMA Approval
P
97
0053
NIDEK EC-5000 EXCIMER LASER SYSTEM
3
PMA Approval
P
99
0027
TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z)
3
PMA Approval
P
93
0034
INFINITY LS EXCIMER LASER SYSTEM
3
PMA Approval
P
97
0043
LADAR VISION EXCIMER LASER SYSTEM
3
PMA Approval
P
97
0043
LADAR VISION EXCIMER LASER SYSTEM
3
PMA Approval
P
99
0010
VISX EXCIMER LASER SYSTEM MODEL C STAR
3
PMA Approval
P
98
0008
LASERSCAN LSX EXCIMER LASER SYSTEM
3
PMA Approval
P
93
0034
SVS APEX PLUS EXCIMER LASER WORKSTATION
3
PMA Approval
P
93
0034
SVS APEX PLUS EXCIMER LASER WORKSTATION WITH THE EMPHASIS DISCS
3
PMA Approval
P
97
0053
NIDEK EC-5000 EXCIMER LASER SYSTEM (PARK)
3
PMA Approval
P
97
0056
BAUSCH & LOMB KERACOR 116 EXCIMER LASER SYSTEM
3
PMA Approval
P
97
0043
LADAR VISION TREATMENTS
3
PMA Approval
P
97
0043
LADARVISION EXCIMER LASER SYSTEM
3
PMA Approval
P
97
0043
LADAR VISION EXCIMER LASER SYSTEM
3
PMA Approval
P
93
0016
VISX EXCIMER LASER SYSTEM MODELS B AND C FOR PHOTOREFRACTIVE KERATECTOMY (PRK)
3
PMA Approval
P
97
0053
EC-5000 EXCIMER LASER SYSTEM
3
PMA Approval
P
93
0016
VISX STAR S2 EXCIMER LASER SYSTEM
3
PMA Approval
P
97
0043
LADARVISION EXCIMER LASER SYSTEM
3
PMA Approval
P
93
0034
SVS APEX AND SVS APEX PLUS EXCIMER LASER WORKSTATIONS
3
PMA Approval
P
97
0005
KREMER LASER SYSTEM
3
PMA Approval
P
91
0067
SVS APEX PLUS EXCIMER LASER WORKSTATION
3
PMA Approval
P
93
0034
SVS APEX PLUS EXCIMER LASER WORKSTATION
3
PMA Approval
P
96
0019
LASERVISION/VISX EXCIMER LASER FOR PRK AND PTK (MOBILEXCIMER)
3
PMA Approval
P
93
0016
VISX STAR S2 EXCIMER LASER SYSTEM
3
PMA Approval
P
93
0034
SVS APEX PLUS EXCIMER LASER WORKSTATION AND EMPHASIS DISC
3
PMA Approval
P
93
0016
VISX EXCIMER LASER SYSTEM MODELS B AND C
3
PMA Approval
P
93
0016
VISX EXCIMER LASER SYSTEM MODELS B AND C
3
PMA Approval
P
93
0016
VISX EXCIMER LASER SYSTEM MODELS B AND C
3
PMA Approval
P
96
0019
MOBILEXCIMER FOR PTK AND PRK
3
PMA Approval
P
93
0034
SVS APEX APEX EXIMER LASER WORKSTATION
3
PMA Approval
P
91
0067
SVS APEX PLUS EXCIMER LASER WORKSTATION
3
PMA Approval
P
91
0067
SVS APEX PLUS EXCIMER LASER WORKSTATION
3
PMA Approval
P
93
0034
SVS APEX PLUS EXIMER LASER SYSTEM
3
PMA Approval
P
93
0034
SVS APEX (FORMERLY OMNIMED) EXCIMER LASER SYSTEM FOR PHOTOREFRACTIVE KERATECTOMY (PRK)
3
PMA Approval
P
93
0034
SVS APEX APEX EXIMER LASER WORKSTATION
3
PMA Approval
P
96
0019
LASERVISION/VISX EXCIMER LASER MODEL C
3
PMA Approval
P
93
0016
VISX EXCIMER LASER SYSTEM MODELS B AND C
3
PMA Approval
P
93
0034
SVS APEX APEX EXIMER LASER WORKSTATION
3
PMA Approval
P
93
0016
VISX EXCIMER LASER SYSTEM MODELS B AND C
3
PMA Approval
P
93
0016
VISX EXCIMER LASER SYSTEM MODELS B AND C
3
PMA Approval
P
93
0034
SVS APEX EXCIMER LASER SYSTEM
3
PMA Approval
P
91
0062
VISX MODELB/MODEL C EXCIMER LASER SYSTEM
3
PMA Approval
P
91
0067
EXCIMED(TM) UV200LA LASER SYSTEM
3
PMA Approval
LZU
Plug, Punctum
U
Product Code
MRJ
Ring, Endocapsular
3
Product Code
MSI
Solution, Cleaning / Lubricating, Artificial Eye
3
Product Code
MTA
Lens, Intraocular, Phakic
3
Product Code
MUR
Graft, Sclera, Reinforcement
3
Product Code
MWD
Electrosurgical, Radio Frequency, Refractive Correction
3
Product Code
NBF
Prosthesis, Retinal
F
Product Code
NCJ
Telescope, Implantable, Miniature
3
Product Code
ODK
Refractive Corneal Implant
F
Product Code
OKS
Lacrimal Stents And Intubation Sets
U
Product Code
OTL
Femtosecond Laser System For Refractive Correction
3
Product Code
OXW
Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy
N
Product Code
PFZ
Ophthalmic Sealant
3
Product Code
QBT
Artificial Iris
3
Product Code
QIT
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
3
Product Code
QCW
Corneal Storage Media With Preservatives Including Anti-Fungal
2
Product Code
SAX
Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
2
Product Code
QQJ
Applicator, Negative Pressure, External, Ocular
2
Product Code
SDE
Light Based Device For Dry Age-Related Macular Degeneration
2
Product Code
QUR
Prescription Spectacle Lenses To Reduce The Progression Of Myopia
2
Product Code
Submissions with No Product Code
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 25 January 2026 at 3:41 am
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P910067
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SVS APEX PLUS EXCIMER LASER WORKSTATION
Page Type
PMA Approval
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
ALCON RESEARCH, LTD. DBA ALCON LABORATORIES, INC.
Trade Name
EXCIMED(TM) UV200LA LASER SYSTEM
Generic Name
Excimer laser system
Decision Date
3/10/1995
Days to Decision
1206 days
Decision Code
APWD
FDA Decision
Withdrawal after approval
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Miscellaneous
OGO
Intraocular Pressure Lowering Implant
QQU
Digital Therapy Device For Amblyopia
HPX
Lens, Contact (Polymethylmethacrylate)
LOG
Catheter, Balloon For Retinal Reattachment
LOH
System, Identification, Contact Lens
LOI
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
LQB
Medical Computers And Software For Ophthalmic Use
LQE
Implant, Corneal, Refractive
LXQ
Cup, Eye
LYX
Media, Corneal Storage
LZQ
Tissue Adhesive For Ophthalmic Use
LZR
Ultrasound, Cyclodestructive
LZS
Excimer Laser System
P
06
0004
MEL 80 EXCIMER LASER SYSTEM
P
03
0008
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
P
02
0050
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
P
99
0027
TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z)
P
99
0010
VISX EXCIMER LASER SYSTEM MODEL C STAR
P
98
0008
LASERSCAN LSX EXCIMER LASER SYSTEM
P
97
0056
BAUSCH & LOMB KERACOR 116 EXCIMER LASER SYSTEM
P
97
0053
EC-5000 EXCIMER LASER SYSTEM
P
97
0043
LADARVISION EXCIMER LASER SYSTEM
P
97
0005
KREMER LASER SYSTEM
P
03
0008
WaveLight EX500 Laser
P
93
0016
iDESIGN Refractive Studio
P
93
0016
iDESIGN Refractive Studio
P
03
0008
WaveLight EX500 Laser System/Allegro Topolyzer Vario
P
02
0050
WaveLight EX500 Laser System/Allegro Topolyzer Vario
P
03
0008
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
P
02
0050
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
P
93
0016
STAR S4 IR Excimer Laser System and iDESIGN Refractive Studio
P
93
0016
iDESIGN Refractive Studio and STAR S4 IR Excimer Laser Systems
P
93
0016
iDESIGN Refractive Studio
P
91
0062
STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System
P
93
0016
STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System
P
99
0010
STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System
P
03
0008
WaveLight Analyzer II, ALLEGRO Topolyzer VARIO, Patient Bed Swivel
P
02
0050
ALLEGRO Topolyzer VARIO and Patient Bed Swivel
P
93
0016
iDESIGN Refractive Studio; STAR Excimer Laser System
P
02
0050
WaveLight EX500 Excimer Laser System
P
03
0008
WaveLight EX500 Excimer Laser System
P
02
0050
WaveLight EX500 Laser System with Patient Bed Swivel 1125
P
03
0008
WaveLight EX500 Laser System with Patient Bed Swivel 1125
P
93
0016
iDESIGNRefractive Studio, STAR Excimer Laser System
P
02
0050
WaveLight EX500 Laser System
P
03
0008
WaveNet Planning Software
P
02
0050
Wave Light EX500 Laser
P
03
0008
Wave Light EX500 Laser
P
93
0016
STAR Excimer Laser System
P
97
0053
Nidek EC-5000 Excimer Laser System
P
03
0008
WaveLight EX500 Laser System
P
02
0050
WaveLight EX500 Laser System
P
93
0016
Star S4 IR Excimer Laser System
P
93
0016
STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System
P
93
0016
Star S4 IR Excimer Laser System
P
97
0053
EC-5000 EXCIMER LASER SYSTEM
P
02
0050
Allegro Topolyzer Vario
P
03
0008
Allegro Topolyzer Vario
P
93
0016
iDesign Advanced WaveScan Studio
P
93
0016
STAR EXCIMER LASER SYSTEM
P
02
0050
WAVELIGHT EX500 EXCIMER LASER SYSTEM, ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
P
93
0016
IDESIGN ADVANCED WAVESCAN STUDIO, STAR EXCIMER LASER SYSTEM
P
93
0016
STAR EXCIMER LASER SYSTEM
P
93
0016
STAR EXCIMER LASER SYSTEM
P
99
0027
TECHNOLAS 217A EXCIMER LASER SYSTEM FOR LASER IN-SITU KERATOMILEUSIS(LASIK), TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALI
P
02
0050
ALLEGRETTO WAVE EYE-Q
P
03
0008
WAVELIGHT EX500 LASER SYSTEM
P
02
0050
WAVELIGHT EX500 LASER SYSTEM
P
93
0016
STAR S4 IR EXCIMER LASER SYSTEM WITH IDESIGN WAVESCAN STUDIO SYSTEM
P
03
0008
WAVELIGHT EX500 LASER SYSTEM
P
02
0050
WAVELIGHT EX500 LASER SYSTEM
P
02
0050
ALLEGRO TOPOLYZER VARIO
P
03
0008
ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
P
03
0008
WAVELIGHT EX500 EXCIMER LASER SYSTEM
P
02
0050
WAVELIGHT EX500 EXCIMER LASER SYSTEM
P
97
0053
NIDEK EXCLAIMER LASER SYSTEM EC-5000
P
02
0050
WAVELIGHT EX500 LASER SYSTEM
P
03
0008
WAVELIGHT EX500 LASER SYSTEM
P
02
0050
WAVE LIGHT EX500 LASER SYSTEM
P
03
0008
WAVE LIGHT EX500 LASER SYSTEM
P
97
0053
NIDEK EXCIMER LASER SYSTEM EC-5000
P
97
0053
NIDEK EXCIMER LASER SYSTEM EC-5000
P
93
0016
STAR EXCIMER LASER SYSTEM
P
91
0062
STAR EXCIMER LASER SYSTEM
P
99
0010
STAR EXCIMER LASER SYSTEM
P
99
0010
STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO
P
91
0062
STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO
P
93
0016
STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO
P
99
0010
STAR, S41R EXCIMER LASER SYSTEM
P
91
0062
STAR S4 IM EXCIMER LASER SYSTEM
P
93
0016
WAVESCAN WAVEFRONT SYSTEM
P
02
0050
WAVELIGHT EX500 EXCIMER LASER SYSTEM
P
03
0008
WAVELIGHT EX500 EXCIMER LASER SYSTEM
P
99
0027
TECHNOLAS 217A EXCIMER LASER AND TEHNOLAS 217Z ZYOPTIX SYSTEMS
P
03
0008
WAVELIGHT EX500 LASER SYSTEM
P
02
0050
WAVELIGHT EX500 LASER SYSTEM
P
02
0050
WAVELIGHT EX500 EXCIMER LASER SYSTEM
P
03
0008
WAVELIGHT EX500 EXCIMER LASER SYSTEM
P
02
0050
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
P
03
0008
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
P
97
0053
NIDEK 2000 EC-5000 EXCIMER LASER SYSTEM
P
02
0050
ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
P
93
0016
WAVESCAN WAVEFRONT SYSTEM
P
99
0027
TECHNOLAS PERFECT VISION 217Z ZYOPTIX SYSTEM
P
03
0008
WAVELIGHT LASER SYSTEM
P
02
0050
WAVELIGHT EX500 EXCIMER LASER SYSTEM
P
03
0008
WAVELIGHT EX 500 LASER SYSTEM
P
02
0050
WAVELIGHT EX500 LASER SYSTEM, ALLEGRO ANALYZER
P
02
0050
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
P
99
0027
TECHNOLAS 217A EXCIMER LASER SYSTEM AND TECHNOLAS 217Z ZYOPTIX SYSTEM
P
97
0053
NIDEK EC-5000 EXCIMER LASER SYSTEM
P
02
0050
ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
P
03
0008
ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
P
93
0016
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)
P
03
0008
ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEMS
P
02
0050
ALLEGRETTO WAVE EXCIMER LASER SYSTEMS
P
02
0050
WAVELIGHT EX500 LASER SYSTEM
P
03
0008
WAVELIGHT EX500 LASER SYSTEM
P
93
0016
STAR EXCIMER LASER & WAVESCAN WAVEFRONT SYSTEM
P
06
0004
MEDITEC MEL 80 EXCIMER LASER SYSTEM
P
93
0016
WAVESCAN WAVEFRONT SYSTEM SOFTWARE VERSION 3.68
P
99
0027
TECHNOLAS 217Z ZYOPTIX SYSTEM
P
99
0027
TECHNOLAS PERFECT VISION 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION
P
99
0027
BAUSCH & LOMB TECHNOLAS T217Z ZYOPTIX LASER SYSTEM
P
93
0016
STAR S4 & STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)
P
99
0027
TECHNOLAS 217A EXCIMER LASER SYSTEM
P
99
0027
BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION
P
99
0027
BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX LASER SYSTEM
P
93
0016
VISX STAR S4 IR EXCIMER LASER SYSTEM
P
93
0016
STAT S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM
P
93
0016
STAT S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM
P
06
0004
MEL 80 EXCIMER LASER SYSTEM
P
99
0027
BAUSCH& LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM
P
93
0016
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) WAVESCAN WAVEFRONT SYSTEM
P
93
0016
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)
P
93
0016
STAR S4 IR EXCIMER LASER SYSTEM & WAVESCAN SYSTEM
P
03
0008
WAVELIGHT ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
P
02
0050
WAVELIGHT ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
P
97
0053
NIDEK EC-5000 EXCIMER LASER
P
93
0016
VISX STAR S4 IR EXCIMER LASER SYSTEM AND WAVESCAN SYSTEM
P
97
0043
LADARVISION 4000 AND LADAR6000 EXCIMER LASER SYSTEMS AND THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE
P
97
0053
NIDEK EC-5000 EXCIMER LASER SYSTEM
P
06
0004
MEL 80 EXCIMER LASER SYSTEM
P
02
0050
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
P
97
0043
LADARVISION 4000 EXCIMER LASER SYSTEM AND THE LADAR 6000 EXCIMER LASER SYSTEM
P
02
0050
ALLEGRETTO WAVE EYE-Q LASER SYSTEM
P
03
0008
ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
P
93
0016
VISX STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM
P
97
0043
LADARVISION 4000 EXCIMER LASER SYSTEM AND THE LADAR 6000 EXCIMER LASER SYSTEM
P
97
0043
LADAR 6000 EXCIMER LASER SYSTEM
P
97
0043
LADARVISION 4000 EXCIMER LASER SYSTEM
P
97
0043
LADAR 6000 EXCIMER LASER SYSTEM
P
03
0008
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
P
99
0027
BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION
P
97
0043
ALCON LADARVISION 4000 EXCIMER LASER SYSTEM-
P
93
0016
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM
P
93
0016
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM
P
93
0016
STAR S4 IR EXCIMER LASER SOFTWARE, VERSION 5.10
P
93
0016
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)
P
93
0016
STAR S4 EXCIMER LASER AND WAVESCAN WAVEFRONT SYSTEMS
P
02
0050
ALLEGRETTO WAVE EXCIMER LASER SYSTEM
P
03
0008
ALLEGRETTO WAVE EXCIMER LASER SYSTEMS
P
93
0016
STAR S4 EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM
P
97
0043
LADARVISION 4000 EXCIMER LASER SYSTEM
P
93
0016
STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM
P
03
0008
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
P
02
0050
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
P
97
0053
NIDEK EC-5000 EXCIMER LASER SYSTEM
P
97
0043
LADAR VISION 4000 EXCIMER LASER SYSTEM
P
97
0043
LADARVISION 4000 EXCIMER LASER SYSTEM
P
03
0008
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
P
99
0027
BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION
P
02
0050
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
P
97
0043
LADARVISION 4000 EXCIMER LASER SYSTEM
P
97
0043
LADARVISION 4000 EXCIMER LASER SYSTEM
P
93
0016
STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM
P
99
0027
TECHNOLAS 217A EXCIMER LASER SYSTEM
P
98
0008
LSX EXCIMER LASER SYSTEM
P
97
0043
LADARVISION 4000 EXCIMER LASER SYSTEM
P
97
0053
NIDEK EC-5000 EXCIMER LASER SYSTEM
P
97
0043
LADARVISION 4000 EXCIMER LASER SYSTEM
P
93
0016
VISX STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM
P
99
0027
TECHNOLAS 217A EXCIMER LASER SYSTEM
P
99
0027
TECHNOLAS 217A EXCIMER LASER SYSTEM
P
98
0008
LASERSCAN LSX EXCIMER LASER SYSTEM
P
93
0016
VISX STAR EXCIMER LASER SYSTEM
P
98
0008
LASERSCAN LSX EXCIMER LASER SYSTEM
P
98
0008
LASERSIGHT LASERSCAN LSX EXCIMER LASER SYSTEM FOR LASER-ASSITED IN SITU KERATOMILEUSIS (LASIK)
P
99
0027
TECHNOLAS(R)217A OPHTHALMIC EXCIMER LASER SYSTEM
P
97
0053
NIDEK EC-5000 EXCIMER LASER SYSTEM
P
93
0016
VISX STAR EXCIMER LASER SYSTEM
P
93
0016
VISX STAR S2/S3 EXCIMER LASER SYSTEM
P
97
0053
NIDEK EC-5000 EXCIMER LASER SYSTEM
P
99
0027
TECHNOLAS 217A EXCIMER LASER SYSTEM
P
98
0008
LASERSCAN LSX EXCIMER LASER
P
97
0053
EC-5000 EXCIMER LASER SYSTEM
P
93
0016
VISX STAR S2 AND S3 EXCIMER LASER SYSTEM
P
97
0043
LADAR VISION EXCIMER LASER SYSTEM (HYPEROPIA)
P
97
0043
LADARVISION EXCIMER LASER SYSTEM
P
98
0008
LASER SCAN LSX EXCIMER LASER
P
97
0043
SUMMIT AUTONOMOUS LADARVISION 4000 SYSTEM
P
97
0043
LADARVISION EXCIMER LASER SYSTEM
P
91
0062
VISX STAR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER)
P
93
0016
VISX STARR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER)
P
99
0010
VISX STAR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER)
P
97
0053
NIDEK EC-5000 EXCIMER LASER SYSTEM
P
99
0027
TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z)
P
93
0034
INFINITY LS EXCIMER LASER SYSTEM
P
97
0043
LADAR VISION EXCIMER LASER SYSTEM
P
97
0043
LADAR VISION EXCIMER LASER SYSTEM
P
99
0010
VISX EXCIMER LASER SYSTEM MODEL C STAR
P
98
0008
LASERSCAN LSX EXCIMER LASER SYSTEM
P
93
0034
SVS APEX PLUS EXCIMER LASER WORKSTATION
P
93
0034
SVS APEX PLUS EXCIMER LASER WORKSTATION WITH THE EMPHASIS DISCS
P
97
0053
NIDEK EC-5000 EXCIMER LASER SYSTEM (PARK)
P
97
0056
BAUSCH & LOMB KERACOR 116 EXCIMER LASER SYSTEM
P
97
0043
LADAR VISION TREATMENTS
P
97
0043
LADARVISION EXCIMER LASER SYSTEM
P
97
0043
LADAR VISION EXCIMER LASER SYSTEM
P
93
0016
VISX EXCIMER LASER SYSTEM MODELS B AND C FOR PHOTOREFRACTIVE KERATECTOMY (PRK)
P
97
0053
EC-5000 EXCIMER LASER SYSTEM
P
93
0016
VISX STAR S2 EXCIMER LASER SYSTEM
P
97
0043
LADARVISION EXCIMER LASER SYSTEM
P
93
0034
SVS APEX AND SVS APEX PLUS EXCIMER LASER WORKSTATIONS
P
97
0005
KREMER LASER SYSTEM
P
91
0067
SVS APEX PLUS EXCIMER LASER WORKSTATION
P
93
0034
SVS APEX PLUS EXCIMER LASER WORKSTATION
P
96
0019
LASERVISION/VISX EXCIMER LASER FOR PRK AND PTK (MOBILEXCIMER)
P
93
0016
VISX STAR S2 EXCIMER LASER SYSTEM
P
93
0034
SVS APEX PLUS EXCIMER LASER WORKSTATION AND EMPHASIS DISC
P
93
0016
VISX EXCIMER LASER SYSTEM MODELS B AND C
P
93
0016
VISX EXCIMER LASER SYSTEM MODELS B AND C
P
93
0016
VISX EXCIMER LASER SYSTEM MODELS B AND C
P
96
0019
MOBILEXCIMER FOR PTK AND PRK
P
93
0034
SVS APEX APEX EXIMER LASER WORKSTATION
P
91
0067
SVS APEX PLUS EXCIMER LASER WORKSTATION
P
91
0067
SVS APEX PLUS EXCIMER LASER WORKSTATION
P
93
0034
SVS APEX PLUS EXIMER LASER SYSTEM
P
93
0034
SVS APEX (FORMERLY OMNIMED) EXCIMER LASER SYSTEM FOR PHOTOREFRACTIVE KERATECTOMY (PRK)
P
93
0034
SVS APEX APEX EXIMER LASER WORKSTATION
P
96
0019
LASERVISION/VISX EXCIMER LASER MODEL C
P
93
0016
VISX EXCIMER LASER SYSTEM MODELS B AND C
P
93
0034
SVS APEX APEX EXIMER LASER WORKSTATION
P
93
0016
VISX EXCIMER LASER SYSTEM MODELS B AND C
P
93
0016
VISX EXCIMER LASER SYSTEM MODELS B AND C
P
93
0034
SVS APEX EXCIMER LASER SYSTEM
P
91
0062
VISX MODELB/MODEL C EXCIMER LASER SYSTEM
P
91
0067
EXCIMED(TM) UV200LA LASER SYSTEM
LZU
Plug, Punctum
MRJ
Ring, Endocapsular
MSI
Solution, Cleaning / Lubricating, Artificial Eye
MTA
Lens, Intraocular, Phakic
MUR
Graft, Sclera, Reinforcement
MWD
Electrosurgical, Radio Frequency, Refractive Correction
NBF
Prosthesis, Retinal
NCJ
Telescope, Implantable, Miniature
ODK
Refractive Corneal Implant
OKS
Lacrimal Stents And Intubation Sets
OTL
Femtosecond Laser System For Refractive Correction
OXW
Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy
PFZ
Ophthalmic Sealant
QBT
Artificial Iris
QIT
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
QCW
Corneal Storage Media With Preservatives Including Anti-Fungal
SAX
Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
QQJ
Applicator, Negative Pressure, External, Ocular
SDE
Light Based Device For Dry Age-Related Macular Degeneration
QUR
Prescription Spectacle Lenses To Reduce The Progression Of Myopia
Submissions with No Product Code
Subpart B—Diagnostic Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Therapeutic Devices
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OP
/
OP-misc
/
LZS
/
P910067
View Source
SVS APEX PLUS EXCIMER LASER WORKSTATION
Page Type
PMA Approval
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
ALCON RESEARCH, LTD. DBA ALCON LABORATORIES, INC.
Trade Name
EXCIMED(TM) UV200LA LASER SYSTEM
Generic Name
Excimer laser system
Decision Date
3/10/1995
Days to Decision
1206 days
Decision Code
APWD
FDA Decision
Withdrawal after approval