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Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
HLD
Engine, Trephine, Accessories, Gas-Powered
1
Product Code
HKP
Instrument, Vitreous Aspiration And Cutting, Battery-Powered
2
Product Code
FCT
Headlight, Fiberoptic Focusing
2
Product Code
FSR
Light, Headband, Surgical
2
Product Code
FTZ
Locator, Magnetic
1
Product Code
HMQ
Marker, Sclera
1
Product Code
HMR
Marker, Ocular
1
Product Code
HMS
Drum, Eye Knife Test
1
Product Code
HMX
Cannula, Ophthalmic
1
Product Code
HMY
Keratome, Battery-Powered
1
Product Code
HMZ
Trabeculotome
1
Product Code
HNA
Spud, Ophthalmic
1
Product Code
HNB
Spoon, Ophthalmic
1
Product Code
HNC
Specula, Ophthalmic
1
Product Code
HND
Spatula, Ophthalmic
1
Product Code
HNE
Snare, Enucleating
1
Product Code
HNF
Scissors, Ophthalmic
1
Product Code
HNG
Rongeur, Lachrymal Sac
1
Product Code
HNH
Ring, Ophthalmic (Flieringa)
1
Product Code
HNI
Retractor, Ophthalmic
1
Product Code
HNJ
Punch, Corneo-Scleral
1
Product Code
HNK
Probe, Trabeculotomy
1
Product Code
HNL
Probe, Lachrymal
1
Product Code
HNM
Needle, Ophthalmic Suturing
1
Product Code
HNN
Knife, Ophthalmic
1
Product Code
HNO
Keratome, Ac-Powered
1
Product Code
HNP
Introducer, Sphere
1
Product Code
HNQ
Hook, Ophthalmic
1
Product Code
HNR
Forceps, Ophthalmic
1
Product Code
HNS
Expressor
1
Product Code
HNT
Erisophake
1
Product Code
HNW
Dilator, Lachrymal
1
Product Code
HNX
Depressor, Orbital
1
Product Code
HNY
Cystotome
1
Product Code
HNZ
Curette, Ophthalmic
1
Product Code
HOA
Compressor, Orbital
1
Product Code
HOB
Clamp, Muscle, Ophthalmic
1
Product Code
HOC
Clip, Iris Retractor
1
Product Code
HOD
Clamp, Eyelid, Ophthalmic
1
Product Code
HOE
Caliper, Ophthalmic
1
Product Code
HOF
Burr, Corneal, Manual
1
Product Code
HOG
Burr, Corneal, Battery-Powered
1
Product Code
HOH
Spectacle, Operating (Loupe), Ophthalmic
1
Product Code
HOY
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
1
Product Code
HOZ
Sponge, Ophthalmic
2
Product Code
HPM
Locator, Metal, Electronic
2
Product Code
HPN
Magnet, Permanent
1
Product Code
HPO
Magnet, Ac-Powered
2
Product Code
HPP
Headlamp, Operating, Battery-Operated
1
Product Code
HPQ
Headlamp, Operating, Ac-Powered
2
Product Code
HPS
Unit, Cryophthalmic
2
Product Code
HPY
Unit, Electrolysis, Battery-Powered, Ophthalmic
1
Product Code
HQA
Unit, Cryotherapy, Ophthalmic
2
Product Code
HQB
Photocoagulator And Accessories
2
Product Code
HQC
Unit, Phacofragmentation
2
Product Code
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
2
Product Code
HQF
Laser, Ophthalmic
2
Product Code
HQO
Unit, Cautery, Thermal, Ac-Powered
2
Product Code
HQP
Unit, Cautery, Thermal, Battery-Powered
2
Product Code
HQQ
Apparatus, Cautery, Radiofrequency, Battery-Powered
2
Product Code
HQR
Apparatus, Cautery, Radiofrequency, Ac-Powered
2
Product Code
HQS
Burr, Corneal, Ac-Powered
1
Product Code
HRF
Engine, Trephine, Accessories, Battery-Powered
1
Product Code
HRG
Engine, Trephine, Accessories, Ac-Powered
1
Product Code
HRH
Trephine, Manual, Ophthalmic
1
Product Code
HRJ
Table, Instrument, Powered, Ophthalmic
1
Product Code
HRK
Table, Instrument, Manual, Ophthalmic
1
Product Code
HRN
Unit, Cryophthalmic, Ac-Powered
2
Product Code
HRO
Unit, Electrolysis, Ac-Powered, Ophthalmic
2
Product Code
HRP
Pen, Marking, Surgical
1
Product Code
KYB
Lens, Guide, Intraocular
1
Product Code
KYG
Device, Irrigation, Ocular Surgery
1
Product Code
LCC
Applicator, Ocular Pressure
2
Product Code
LPO
Gases Used Within Eye To Place Pressure On Detached Retina
3
Product Code
LQJ
Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
2
Product Code
LWL
Fluid, Intraocular
3
Product Code
LXP
Plug, Scleral
2
Product Code
LXS
Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
2
Product Code
LZP
Aid, Surgical, Viscoelastic
3
Product Code
P
22
0009
StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD)
APPR
PMA Approval
P
20
0025
ClearVisc Ophthalmic Viscosurgical Device (OVD)
APPR
PMA Approval
P
11
0007
HEALON ENDOCOAT OPVISCOSURGICAL OPHTHALMIC DEVICE (OVD) (3% SODIUM HYALURONATE)
APPR
PMA Approval
P
00
0046
STAARVISC II
APPR
PMA Approval
P
99
0023
CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE
APPR
PMA Approval
P
96
0011
BIOLON 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID
APPR
PMA Approval
P
89
0047
PROVISC(TM)VISCOELASTIC PREPARATION
APPR
PMA Approval
P
88
0031
VITRAX SODIUM HYALURONATE
APWD
PMA Approval
P
86
0047
HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML
APPR
PMA Approval
P
82
0079
CDS II (SODIUM CHONDROITIN SULFATE)
APWD
PMA Approval
P
81
0025
Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD)
3
PMA Approval
P
20
0025
ClearVisc Ophthalmic Viscosurgical Device (OVD)
3
PMA Approval
P
89
0047
PROVISC Ophthalmic Viscosurgical Device
3
PMA Approval
P
84
0064
VISCOAT Ophthalmic Viscoelastic System, DUOVISC Ophthalmic Viscoelastic System (consists of PRIVSC and VISCOAT)
3
PMA Approval
P
81
0025
Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD)
3
PMA Approval
P
86
0047
OcuCoat OVD
3
PMA Approval
P
81
0031
Healon PRO Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon Duet PRO Dual Pack, Healon GV PRO Sodium Hya
3
PMA Approval
P
11
0007
Healon EndoCoat Ophthalmic Viscosurgical Device (3% Sodium Hyaluronate)
3
PMA Approval
P
81
0031
Ophthalmic Viscoelastic Devices, Healon Duet Dual Pack and Healon Duet PRO Dual Pack
3
PMA Approval
P
81
0031
Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD), Healon GV PRO
3
PMA Approval
P
89
0047
PROVISC Ophthalmic Viscosurgical Device
3
PMA Approval
P
84
0064
VISCOAT Ophthalmic Viscoelastic System, DUOVISC Ophthalmic Viscoelastic System (consists of PROVISC and VISCOAT), and DI
3
PMA Approval
P
81
0025
Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD)
3
PMA Approval
P
84
0064
VISCOAT Ophthalmic Viscoelastic System and DUOVISC Ophthalmic Viscoelastic System
3
PMA Approval
P
89
0047
PROVISC Ophthalmic Viscosurgical Device
3
PMA Approval
P
81
0031
Sodium Hyaluronate Ophtalmic Viscoelastic Devices (OVD), Healon Duet Dual Pack and Healon Duet PRO Dual Pack
3
PMA Approval
P
11
0007
Healon EndoCoat Ophtalmic Viscosurgical Devices (OVD) (3% Sodium Hyaluronate)
3
PMA Approval
P
84
0064
DUOVISC Ophthalmic Viscoelastic System (consists of PROVISC and VISCOAT), DISCOVISC Ophthalmic Viscosurgical Device
3
PMA Approval
P
89
0047
PROVISC Ophthalmic Viscosurgical Device
3
PMA Approval
P
00
0046
Ophthalmic Viscoelastic
3
PMA Approval
P
96
0011
BIOLON
3
PMA Approval
P
96
0011
BIOLON
3
PMA Approval
P
81
0031
Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD)
3
PMA Approval
P
84
0064
Ophthalmic Viscosurgical Devices
3
PMA Approval
P
84
0064
VISCOAT/DUOVISC Ophthalmic Viscoelastic System
3
PMA Approval
P
84
0064
VISCOAT Opthalmic Viscoelastic System, DUOVISC Opthalmic Viscoelastic System
3
PMA Approval
P
89
0047
PROVISC Opthalmic Viscoelastic Device
3
PMA Approval
P
96
0011
BIOLON
3
PMA Approval
P
96
0011
BVI 1% OVD (formerly BD 1% OVD and Biolon)
3
PMA Approval
P
81
0031
Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon, Healon GV, Healon5, Healon Ultimate Dual Pack, Healon
3
PMA Approval
P
96
0011
BVI 1%OVD (fonnerly BD 1%OVD and Biolon)
3
PMA Approval
P
96
0011
BVI 1% OVD (1% sodium hyaluronate viscoelastic surgical aid fluid)
3
PMA Approval
P
84
0064
Duovisc, Viscoat, Discovisc Ophthalmic Viscosurgical Devices
3
PMA Approval
P
89
0047
Provisc Ophthalmic Viscosurgical Devices
3
PMA Approval
P
81
0031
HEALON DUET DUAL PACK
3
PMA Approval
P
11
0007
HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD) (3% SODIUM HYALURONATE), MODEL VT585
3
PMA Approval
P
84
0064
VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE; DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE (WITH PROVISC IN LATEX-FREE PACK)
3
PMA Approval
P
89
0047
PROVISC Ophthalmic Viscosurgical Device (latex-ftee packaging configuration)
3
PMA Approval
P
84
0064
OPHTHALMIC VICOSURGICAL DEVICE (OVD)
3
PMA Approval
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
81
0031
Healon, Healo GV, Healon 5, Healon Ulrimate Dual Pack, Healon Duet Dual Pack products
3
PMA Approval
P
81
0025
Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD)
3
PMA Approval
P
86
0047
OcuCoat OVD
3
PMA Approval
P
89
0047
PROVISC OVD
3
PMA Approval
P
84
0064
Ophthalmic Viscosurgical Devices
3
PMA Approval
P
00
0046
Ophthaalmic Viscoelastic
3
PMA Approval
P
84
0064
VISCOAT, DISCOCISC Ophthalmic Viscosurgical Device
3
PMA Approval
P
89
0047
PROVISC Ophthalmic Viscosurgical Devices
3
PMA Approval
P
86
0047
OcuCoat OVD
3
PMA Approval
P
81
0025
AMVISC & AMVISC PLUS OVD
3
PMA Approval
P
81
0031
HEALON DUET DUAL PACK
3
PMA Approval
P
11
0007
HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICES (OVD) (3% SODIUM HYALURONATE)
3
PMA Approval
P
84
0064
DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES
3
PMA Approval
P
81
0031
Healon Ultimate Dual Pack, HEALON, HEALON GV, HEALON5, and Healon Duet Dual Pack products
3
PMA Approval
P
11
0007
HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD) (3% Sodium Hyaluronate)
3
PMA Approval
P
99
0023
CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
99
0023
CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, HEALON ULTIMATE DUAL PACK, AND HEALON DUET
3
PMA Approval
P
84
0064
VISCOAT OPHTHALMIC VISCOSURGICAL DEVICES; DUOVISC OPTHALMIC VISCOSURGICAL DEVICES; DISCOVISC OPTHALMIC VISCOSURGICAL DEV
3
PMA Approval
P
99
0023
CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
3
PMA Approval
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
99
0023
CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
3
PMA Approval
P
11
0007
HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICES (OVD), (3% SODIUM HYALURONATE)
3
PMA Approval
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES-HEALON, HEALON GV, HEALON5 PRODUCTS, HEALON ULTIMATE DUAL PACK, AND H
3
PMA Approval
P
86
0047
OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD)- HEALON5
3
PMA Approval
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD)-HEALON, HEALON GV, HEALON5, AND HEALON ULTIMATE DUAL PACK
3
PMA Approval
P
84
0064
VISCOAT & PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (LATEX-FREE PACKAGING CONFIGURATION ONLY FOR PROVISC)
3
PMA Approval
P
89
0047
DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE (WITH PROVISC IN LATEX-FREE PACKAGING CONFIGURATION ONLY)
3
PMA Approval
P
84
0064
VISCOAT OPHTHALMIC VISCOSURICAL DEVICE, DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5
3
PMA Approval
P
11
0007
HEALON ENDOCOAT OPTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
86
0047
OCUCOAT OVD
3
PMA Approval
P
84
0064
DUOVISC AND DISCOVISC
3
PMA Approval
P
89
0047
PROVISC
3
PMA Approval
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
84
0064
VISCOAT,DUOVISC,DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5 PRODUCTS, HEALON ULTIMATE DUAL
3
PMA Approval
P
81
0025
AMVISC AND AMVISC PLUS VISCOSURGICAL DEVICE
3
PMA Approval
P
96
0011
BVI 1% OVD
3
PMA Approval
P
00
0046
OPHTHALMICS- ANIKAVISC, OPTIVISC AND NUVISC
3
PMA Approval
P
00
0046
STAARVISC, OPTIVISC AND ANIKAVISC SODIUM HYALURONATE
3
PMA Approval
P
96
0011
BVI 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)
3
PMA Approval
P
84
0064
VISCOAT, DUOVISC,DISCOVISC
3
PMA Approval
P
89
0047
PROVISC
3
PMA Approval
P
00
0046
NUVISC
3
PMA Approval
P
86
0047
OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
3
PMA Approval
P
99
0023
CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE (QVD)
3
PMA Approval
P
00
0046
STAARVISC, OPTIVISC, AND ANIKAVISC SODIUM HYALURONATE
3
PMA Approval
P
00
0046
STAARVISC II, SHELLGEL
3
PMA Approval
P
96
0011
BVI 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)
3
PMA Approval
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES-HEALON, HEALON GV AND HEALON5
3
PMA Approval
P
81
0025
AMVISC 0.8 ML SYRINGE AND AMVISC PLUS, O.8 ML SYRINGE
3
PMA Approval
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
84
0064
DUOVISC & DISCOVISC OPTHALMIC VISCOSURGICAL DEVICES
3
PMA Approval
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES(OVD), HEALON, HEALON GV AND HEALON5 PRODUCTS
3
PMA Approval
P
84
0064
VISCOAT OPTHALMIC VISCOSURGICAL DEVICE; DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
11
0007
AMO HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD),(3% SODIUM HYALURONATE)
3
PMA Approval
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES(OVD),HEALON,HEALONGV,AND HEALON5 PRODUCTS
3
PMA Approval
P
96
0011
BVI 1%OVD
3
PMA Approval
P
11
0007
HEALON ENDOCOAT OPHTHALMIC VISCOELASTIC DEVICES (OVD)
3
PMA Approval
P
11
0007
HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
3
PMA Approval
P
81
0025
AMVISC AND AMVISC PLUS OPHTHALMIC VISCOSURICAL DEVICE (OVD)
3
PMA Approval
P
11
0007
AMO HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
3
PMA Approval
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD) HEALON,HEALON GV, AND HEALON5 PRODUCTS
3
PMA Approval
P
84
0064
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
89
0047
VISCOAT, DUROVISC AND DISCOVISC DEVICES OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
96
0011
BV1 1% OVD (1% SODIUM HYALURONATE VISCCOELASTIC SURGICAL AID FLUID)
3
PMA Approval
P
86
0047
OCUCOAT HPMC VISCOELASTIC
3
PMA Approval
P
81
0031
HEALON SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON ENDOCOAT OPHTHALMIC VISCOELASTIC DEVICE (OVD) (3
3
PMA Approval
P
84
0064
VISCOAT AND DUOVISC OPHTHALMIC VISCOSURGICAL DEVICES (OVD)
3
PMA Approval
P
11
0007
ABBOTT MEDICAL OPTICS (AMO) HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELEASTIC DEVICES (OVD) HEALON, HEALON GV AND HEALON5
3
PMA Approval
P
86
0047
OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
3
PMA Approval
P
81
0025
AMVISC AND AMVISC PLUS OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
81
0025
AMVISC/AMVISC PLUS OVDS
3
PMA Approval
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
84
0064
DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
11
0007
HEALON ENDOCOAT OPVISCOSURGICAL OPHTHALMIC DEVICE (OVD) (3% SODIUM HYALURONATE)
3
PMA Approval
P
81
0025
AMVISC & AMVISC PLUS
3
PMA Approval
P
81
0025
AMVISC & AMVISC PLUS
3
PMA Approval
P
86
0047
OCUCOAT (2% HYDROXPROPYLMETHYLCELLULOSE SOLUTION)
3
PMA Approval
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5 PRODUCTS
3
PMA Approval
P
96
0011
BVI 1% OVD (!% SODIUM HYALURONATE VICSCOELASTIC SURGICAL AID FLUID
3
PMA Approval
P
00
0046
STAARVISC II & SHELLGEL SODIUM HYAURONATE
3
PMA Approval
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
3
PMA Approval
P
84
0064
DISCOVISC OPTHALMIC VISCOSURGICAL DEVICE (OVD) & DUOVISC VISCOELASTIC SYSTEM
3
PMA Approval
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON 5 PRODUCTS
3
PMA Approval
P
84
0064
DISCOVISC OPTHALMIC VISCOSURGICAL DEVICE (OVD)
3
PMA Approval
P
89
0047
PROVISC OPTHALMIC VISCOSURGICAL DEVICE (OVD)
3
PMA Approval
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, HEALON5
3
PMA Approval
P
86
0047
OCUCOAT SYRINGE PRODUCT
3
PMA Approval
P
84
0064
DISCOVISC OPTHALMIC VISCOSURGICAL DEVICE (OVD) & DUOVISC VISCOELASTIC SYSTEM
3
PMA Approval
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
3
PMA Approval
P
96
0011
BVI 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)
3
PMA Approval
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
84
0064
VISCOAT/DUOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES
3
PMA Approval
P
81
0025
AMVISC & AMVISC PLUS (OPHTHALMIC VISCOSURGICAL DEVICES)
3
PMA Approval
P
00
0046
STAARVISC II & SHELLGEL SODIUM HYALURONATE
3
PMA Approval
P
00
0046
STAARVISC II, OPTIVISC/ANIKAVISC/SODIUM HYALURONATE
3
PMA Approval
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV & HEALON 5 PRODUCTS
3
PMA Approval
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
3
PMA Approval
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD)
3
PMA Approval
P
84
0064
VISCOAT/DISCOVISC/DUOVISC
3
PMA Approval
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
99
0023
CELLUGEL
3
PMA Approval
P
84
0064
DISCOVISC, VISCOAT AND DUOVISC
3
PMA Approval
P
89
0047
PROVIS OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
96
0011
BVI 1% OVD-SODIUM HYALURONATE VISCOELASTIC
3
PMA Approval
P
96
0011
BVI 1% OVD-SODIUM HYALURONATE VISCOELASTIC
3
PMA Approval
P
00
0046
ANIKA VISC
3
PMA Approval
P
00
0046
STAARVISC II & SHELLGEL SODIUM HYALURONATE
3
PMA Approval
P
81
0025
AMVISC/AMVISC PLUS (OPHTHALMIC VISCOSURGICAL DEVICES)
3
PMA Approval
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVOCES (OVD), HEALON GV, HEALON5 PRODUCTS
3
PMA Approval
P
99
0023
CELLUGEL
3
PMA Approval
P
84
0064
DISCOVISC, VISCOAT AND DUOVISC
3
PMA Approval
P
89
0047
PROVISC
3
PMA Approval
P
89
0047
PROVISC
3
PMA Approval
P
84
0064
DISCOVISC/VISCOAT/DUOVISC
3
PMA Approval
P
99
0023
CELLUGEL
3
PMA Approval
P
89
0047
DISCOVISC, VISCOAT AND DUOVISC
3
PMA Approval
P
84
0064
DISCOVISC, VISCOAT, AND DUOVISC
3
PMA Approval
P
96
0011
BD 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)
3
PMA Approval
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
3
PMA Approval
P
00
0046
OPTIVISC
3
PMA Approval
P
96
0011
BD 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)
3
PMA Approval
P
96
0011
BD 1% OVD ( 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)
3
PMA Approval
P
96
0011
BD 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)
3
PMA Approval
P
86
0047
OCUCOAT
3
PMA Approval
P
99
0023
CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
84
0064
VISCOAT, DUOVISC & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
99
0023
CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
84
0064
VISCOAT/DUOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
84
0064
VISCOAT/DUOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
88
0031
HEALON D SODIUM HYALURONATE SOLUTION
3
PMA Approval
P
99
0023
CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
84
0064
VISCOAT, DUOVISC, AND DISCOVIS OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
84
0064
DUOVISC VISCOELASTIC SYSTEM & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
99
0023
CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
84
0064
VISCOAT, DUOVISC, DISCOVISC, PROVISC AND CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICES
3
PMA Approval
P
81
0031
HEALON, HEALON GV/HEALON 5 SODIUM HYALURONATE OPHTHALMIC VISCOSURGICAL DEVICES
3
PMA Approval
P
88
0031
VITRAX/HEALON D SODIUM HYALURONATE SOLUTION OPHTHALMIC VISCOSURGICAL DEVICES
3
PMA Approval
P
88
0031
HEALON D
3
PMA Approval
P
81
0031
HEALON, HEALON GV & HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
3
PMA Approval
P
86
0047
OCUCOAT
3
PMA Approval
P
86
0047
OCUCOAT
3
PMA Approval
P
99
0023
CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
84
0064
VISCOAT AND DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
86
0047
OCUCOAT
3
PMA Approval
P
96
0011
BD OVD 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY
3
PMA Approval
P
84
0064
VISCOAT, DUOVISC & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
84
0064
VISCOAT,DUOVISC & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
96
0011
BIOLON 1% SODIUM HYALURONATE
3
PMA Approval
P
84
0064
VISCOAT, DUOVISC AND DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES
3
PMA Approval
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
81
0031
HEALON,HEALON GV, & HEALON5 SODIUM HYALURONATE VISCOELASTIC
3
PMA Approval
P
81
0031
HEALON, HEALON GV AND HEALON5 SODIUM HYLAURONATE OPHTHALMIC VISCOELASTIC DEVICES
3
PMA Approval
P
81
0031
HEALON SODIUM HYALURONATE VISCOELASTIC PRODUCTS
3
PMA Approval
P
86
0047
OCUCOAT
3
PMA Approval
P
96
0011
BD 1% OVD
3
PMA Approval
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES ? HEALON, HEALON GV, AND HEALON5
3
PMA Approval
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
3
PMA Approval
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
3
PMA Approval
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
3
PMA Approval
P
81
0031
HEALON,HEALON GV AND HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
3
PMA Approval
P
81
0025
AMVISC & AMVISC PLUS
3
PMA Approval
P
00
0046
STAARVISC II AND SHELLGEL SODIUM HYALURONATE
3
PMA Approval
P
84
0064
VISCOAT, DUOVISC AND DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES
3
PMA Approval
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
81
0025
AMVISC AND AMVISC PLUS
3
PMA Approval
P
00
0046
STAARVISC II, SHELLGEL AND COEASE
3
PMA Approval
P
84
0064
DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
00
0046
STAARVISC II SODIUM HYALURONATE
3
PMA Approval
P
84
0064
VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
96
0011
BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY
3
PMA Approval
P
00
0046
SHELLGEL SODIUM HYALURONATE
3
PMA Approval
P
84
0064
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE, PROVISC PACKAGED IN DUOVISC VISCOELASTIC SYSTEM AND DISCOVISC OPHTHALMIC VISCO
3
PMA Approval
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
84
0064
DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
84
0064
DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
81
0031
HEALON SODIUM HYALURONATE VISCELASTIC PRODUCTS, HEALON,HEALON GV, HEALON 5
3
PMA Approval
P
96
0011
BIOLON (1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY)
3
PMA Approval
P
81
0025
AMVISC & AMVISC PLUS
3
PMA Approval
P
00
0046
STAARVISC II, SHELLGEL, COEASE SODIUM HYALURONATE
3
PMA Approval
P
86
0047
SILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT
3
PMA Approval
P
81
0025
AMVISC TM & AMVISC TM PLUS
3
PMA Approval
P
00
0046
STAARVISC II,SHELLGEL AND COEASE
3
PMA Approval
P
86
0047
OCUCOAT, PMMA AND SILICONE INTRAOCULAR LENSES
3
PMA Approval
P
99
0023
CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
84
0064
DUOVISC VISCOELASTIC SYSTEM
3
PMA Approval
P
89
0047
PROVISC OPHTHALMIC VICOSURGICAL DEVICE
3
PMA Approval
P
81
0031
HEALON SODIUM HYALURONATE
3
PMA Approval
P
86
0047
OCUCOAT (2% HYDROXYPROPYLMETHYLCELLULOSE SOLUTION)
3
PMA Approval
P
99
0023
CELLUGEL OPHTHALMIC VISCOSURGICAL
3
PMA Approval
P
81
0025
AMVISC & AMVISC PLUS
3
PMA Approval
P
86
0047
OCUCOAT
3
PMA Approval
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
84
0064
VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
00
0046
STAARVISC II, SHELLGEL AND COEASE
3
PMA Approval
P
86
0047
OCUCOAT(2%HYDROXYPROPYLMETHLCELLULOSE SOLUTION)
3
PMA Approval
P
86
0047
OCUCOAT(2%HYDROXYPROPYLMETHYLCELLULOSE SOLUTION)
3
PMA Approval
P
00
0046
STAARVISC II, SHELLGEL AND COEASE SODIUM HYALURONATE VISCOELASTICS
3
PMA Approval
P
00
0046
STAARVISC II, SHELLGEL AND COEASE SODIUM HYALURONATE VISCOELASTICS
3
PMA Approval
P
00
0046
STAARVISC II,SHELLGEL AND COEASE VISCOELASTICS
3
PMA Approval
P
81
0025
AMVISC AND AMVISC PLUS SODIUM HYALURONATE VISCOELASTICS
3
PMA Approval
P
96
0011
BIOLON (1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY)
3
PMA Approval
P
00
0046
STAARVISC II SODIUM HYALURONATE AND SHELLGEL SODIUM HYALURONATE
3
PMA Approval
P
81
0031
HEALON SODIUM HYALURONATE
3
PMA Approval
P
81
0025
AMVISC/AMVISC PLUS SODIUM HYALURONATE
3
PMA Approval
P
00
0046
COEASE SODIUM HYALURONATE
3
PMA Approval
P
96
0011
BIOLON(1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY)
3
PMA Approval
P
84
0064
VISCOAT ORPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
00
0046
SHELLGEL(TM) SODIUM HYALURONATE
3
PMA Approval
P
00
0046
STAARVISC II
3
PMA Approval
P
96
0011
BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY
3
PMA Approval
P
96
0011
BIOLON(TM) 1% SODIUM HYALURONATE
3
PMA Approval
P
84
0064
VISCOAT(R) SODIUM HYALURONATE
3
PMA Approval
P
89
0047
DUOVISC LABELING INSERT FOR PROVISC(R) SODIUM HYALURONATE PMA
3
PMA Approval
P
81
0031
HEALON 5 SODIUM HYALURONATE
3
PMA Approval
P
96
0011
BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY
3
PMA Approval
P
99
0023
CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
99
0023
CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE
3
PMA Approval
P
81
0031
HEALON(R) SODIUM HYALURONATE
3
PMA Approval
P
88
0031
AMO VITRAX (SODIUM HYALURONATE) VISCOELASTIC SOLUTION
3
PMA Approval
P
96
0011
BIOLON 1% SODIUM HYALURONATE
3
PMA Approval
P
96
0011
BIOLON TM
3
PMA Approval
P
96
0011
BIOLON 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID
3
PMA Approval
P
96
0011
BIOLON 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID
3
PMA Approval
P
84
0064
VISCOAT(R) VISCOELASTIC SOLUTION
3
PMA Approval
P
84
0064
VISCOAT VISCOELASTIC SOLUTION
3
PMA Approval
P
89
0047
PROVISC VISCOELASTIC MATERIAL
3
PMA Approval
P
84
0064
VISCOAT(R)
3
PMA Approval
P
88
0031
AMO(R) VITRAX(R) VISCOELASTIC SOLUTION
3
PMA Approval
P
88
0031
AMO(R) VITRAX(R) VISCOELASTIC SOLUTION
3
PMA Approval
P
86
0047
OCUCOAT (2% HYDROXYPROPYLMETHYLCELLULOSE SOLUTION)
3
PMA Approval
P
89
0047
PROVISC VISCOELASTIC MATERIAL
3
PMA Approval
P
84
0064
VISCOAT VISCOELASTIC SOLUTION
3
PMA Approval
P
88
0031
AMO(R) VITRAX(R) VISCOELASTIC SOLUTION
3
PMA Approval
P
88
0031
AMO VITRAX (SODIUM HYALURONATE)
3
PMA Approval
P
84
0064
DUOVISC VISCOELASTIC SYSTEM
3
PMA Approval
P
89
0047
DUOVISC VISCOELASTIC SYSTEM
3
PMA Approval
P
84
0064
VISCOAT VISCOELASTIC SYSTEM
3
PMA Approval
P
89
0047
DUOVISC VISCOELASTIC SYSTEM
3
PMA Approval
P
89
0047
DUOVISC VISCOELASTIC SYSTEM
3
PMA Approval
P
84
0064
DUOVISC VISCOELASTIC SYSTEM
3
PMA Approval
P
86
0047
OCUCOAT (2% HYDROXYPROPYLMETHYLCELLULOSE)
3
PMA Approval
P
86
0047
HYDROXYPROPYLMETHYLCELLULOSE 2% OCCUCOAT (R)
3
PMA Approval
P
81
0031
HEALON(R) VISCOELASTIC PRODUCTS
3
PMA Approval
P
84
0064
VISCOAT(TM)
3
PMA Approval
P
89
0047
PROVISC TM VISCOELASTIC PREPARATION
3
PMA Approval
P
81
0025
AMVISC (R)
3
PMA Approval
P
81
0031
HEALON(R) VISCOELASTIC PRODUCTS
3
PMA Approval
P
89
0047
PROVISC TM VISCOELASTIC PREPARATION
3
PMA Approval
P
86
0047
HYDROXYPROPYLMETHYLCELLULOSE 2% OCCUCOAT (R)
3
PMA Approval
P
89
0047
PROVISC TM VISCOELASTIC PREPARATION
3
PMA Approval
P
84
0064
VISCOAT(TM)
3
PMA Approval
P
88
0031
AMO(R) VITRAX(R) VISCOELASTIC SOLUTION
3
PMA Approval
P
86
0047
HYDROXYPROPYLMETHYLCELLULOSE 2% OCCUCOAT (R)
3
PMA Approval
P
89
0047
PROVISC TM VISCOELASTIC PREPARATION
3
PMA Approval
P
81
0031
HEALON GV(TM)
3
PMA Approval
P
88
0031
VITRAX OPHTHALMIC SURGICAL AID
3
PMA Approval
P
88
0031
VITRAX OPHTHALMIC SURGICAL AID
3
PMA Approval
P
88
0031
VITRAX OPHTHALMIC SURGICAL AID
3
PMA Approval
P
89
0047
PROVISC TM VISCOELASTIC PREPARATION
3
PMA Approval
P
86
0047
HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML, DGR,INC.
3
PMA Approval
P
86
0047
HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML, MDR CORP.
3
PMA Approval
P
86
0047
HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML, WORLD OPTICS
3
PMA Approval
P
81
0031
HEALON(R)
3
PMA Approval
P
88
0031
VITRAX OPHTHALMIC SURGICAL AID
3
PMA Approval
P
81
0031
HEALON
3
PMA Approval
P
89
0047
PROVISC(TM)VISCOELASTIC PREPARATION
3
PMA Approval
P
90
0010
ORCOLON (R) (POLYACRYLAMIDE)
3
PMA Approval
P
90
0010
ORCOLON (R) (POLYACRYLAMIDE)
3
PMA Approval
P
86
0047
HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML
3
PMA Approval
P
84
0064
VISCOAT(TM)
3
PMA Approval
P
84
0064
VISCOAT(TM)
3
PMA Approval
P
84
0064
VISCOAT(TM)
3
PMA Approval
P
84
0064
VISCOAT(TM)
3
PMA Approval
P
86
0047
HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML
3
PMA Approval
P
81
0025
AMVISC (R)
3
PMA Approval
P
81
0031
HEALON
3
PMA Approval
P
88
0031
VITRAX SODIUM HYALURONATE
3
PMA Approval
P
81
0025
AMVISC (R)
3
PMA Approval
P
81
0031
HEALON
3
PMA Approval
P
81
0025
AMVISC (R)
3
PMA Approval
P
86
0047
HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML
3
PMA Approval
P
81
0025
AMVISC (R)
3
PMA Approval
P
81
0025
AMVISC (R)
3
PMA Approval
P
81
0025
AMVISC (R)
3
PMA Approval
P
84
0064
VISCOAT(TM)
3
PMA Approval
P
84
0064
VISCOAT(TM)
3
PMA Approval
P
84
0064
VISCOAT(TM)
3
PMA Approval
P
81
0025
AMVISC (R)
3
PMA Approval
P
81
0025
HYVISC(R)
3
PMA Approval
P
81
0031
HEALON
3
PMA Approval
P
84
0064
VISCOAT(TM)
3
PMA Approval
P
84
0064
VISCOAT(TM)
3
PMA Approval
P
84
0064
VISCOAT(TM)
3
PMA Approval
P
82
0079
CDS II (SODIUM CHONDROITIN SULFATE)
3
PMA Approval
P
81
0031
HEALON
3
PMA Approval
P
81
0025
AMVISC(TM)
3
PMA Approval
P
84
0064
VISCOAT(TM)/DVOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES
3
PMA Approval
P
81
0031
HEALON
3
PMA Approval
P
81
0025
HYVISC(R)
3
PMA Approval
P
81
0025
HYVISC(R)
3
PMA Approval
P
81
0031
HEALON
3
PMA Approval
P
81
0031
HEALON
3
PMA Approval
P
81
0031
HEALON
3
PMA Approval
P
81
0025
HYVISC(R)
3
PMA Approval
P
81
0031
HEALON
3
PMA Approval
P
81
0031
HEALON
3
PMA Approval
P
81
0025
AMVISC(R)
3
PMA Approval
P
81
0031
HEALON, HEALON GV, HEALON5 PRODUCTS SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
3
PMA Approval
MLZ
Vitrectomy, Instrument Cutter
2
Product Code
MMC
Dilator, Expansive Iris (Accessory)
2
Product Code
MOE
Collagen Corneal Shield
1
Product Code
MSR
Tubing, Replacement, Phacofragmentation Unit
2
Product Code
MSS
Folders And Injectors, Intraocular Lens (Iol)
1
Product Code
MUS
Fluidic, Phacoemulsification/Phacofragmentation
2
Product Code
MXO
Laser, System, Phacolysis
2
Product Code
MXY
Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal
1
Product Code
MYD
Keratome, Water Jet
1
Product Code
NCE
Injector, Capsular Tension Ring
1
Product Code
NCR
Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered
2
Product Code
NGY
Cannula, Trocar, Ophthalmic
1
Product Code
NKX
Needle, Phacoemulsification, Reprocessed
2
Product Code
NKY
Blade, Keratome, Reprocessed
1
Product Code
NLA
Knife, Ophthalmic, Reprocessed
1
Product Code
NVB
Intraocular, Pressure Measuring Device
3
Product Code
OHW
Burr, Corneal, Battery Powered, Rust Ring Removal
1
Product Code
OHX
Burr, Corneal, Ac-Powered, Rust Ring Removal
1
Product Code
OJK
Eye Tray
2
Product Code
OOE
Ophthalmic Femtosecond Laser
2
Product Code
OTZ
Graft Insertion Instrument For Endothelial Keratoplasty
1
Product Code
PUL
Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered
2
Product Code
PZG
Surgical Eye Tray
1
Product Code
QDV
Iol Tray
1
Product Code
QDW
Phaco Kit
2
Product Code
QDY
Vitrectomy Kit
2
Product Code
QGJ
Corneal Inlay Inserter Handle
1
Product Code
QQQ
Guide And Positioner, Ophthalmic Drug Delivery Device
1
Product Code
PYU
Sponge, Eyelid Cleaning, Powered
1
Product Code
QUQ
Knife, Intraocular Pressure Lowering
2
Product Code
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
OP
/
subpart-e—surgical-devices
/
LZP
/
P840064
View Source
VISCOAT Ophthalmic Viscoelastic System, DUOVISC Ophthalmic Viscoelastic System (consists of PRIVSC and VISCOAT)
Page Type
PMA Approval
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
ALCON LABORATORIES
Trade Name
VISCOAT(TM)/DVOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES
Generic Name
AID, SURGICAL, VISCOELASTIC
Decision Date
4/30/1986
Days to Decision
517 days
Decision Code
APPR
FDA Decision
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
Subpart B—Diagnostic Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
HLD
Engine, Trephine, Accessories, Gas-Powered
HKP
Instrument, Vitreous Aspiration And Cutting, Battery-Powered
FCT
Headlight, Fiberoptic Focusing
FSR
Light, Headband, Surgical
FTZ
Locator, Magnetic
HMQ
Marker, Sclera
HMR
Marker, Ocular
HMS
Drum, Eye Knife Test
HMX
Cannula, Ophthalmic
HMY
Keratome, Battery-Powered
HMZ
Trabeculotome
HNA
Spud, Ophthalmic
HNB
Spoon, Ophthalmic
HNC
Specula, Ophthalmic
HND
Spatula, Ophthalmic
HNE
Snare, Enucleating
HNF
Scissors, Ophthalmic
HNG
Rongeur, Lachrymal Sac
HNH
Ring, Ophthalmic (Flieringa)
HNI
Retractor, Ophthalmic
HNJ
Punch, Corneo-Scleral
HNK
Probe, Trabeculotomy
HNL
Probe, Lachrymal
HNM
Needle, Ophthalmic Suturing
HNN
Knife, Ophthalmic
HNO
Keratome, Ac-Powered
HNP
Introducer, Sphere
HNQ
Hook, Ophthalmic
HNR
Forceps, Ophthalmic
HNS
Expressor
HNT
Erisophake
HNW
Dilator, Lachrymal
HNX
Depressor, Orbital
HNY
Cystotome
HNZ
Curette, Ophthalmic
HOA
Compressor, Orbital
HOB
Clamp, Muscle, Ophthalmic
HOC
Clip, Iris Retractor
HOD
Clamp, Eyelid, Ophthalmic
HOE
Caliper, Ophthalmic
HOF
Burr, Corneal, Manual
HOG
Burr, Corneal, Battery-Powered
HOH
Spectacle, Operating (Loupe), Ophthalmic
HOY
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
HOZ
Sponge, Ophthalmic
HPM
Locator, Metal, Electronic
HPN
Magnet, Permanent
HPO
Magnet, Ac-Powered
HPP
Headlamp, Operating, Battery-Operated
HPQ
Headlamp, Operating, Ac-Powered
HPS
Unit, Cryophthalmic
HPY
Unit, Electrolysis, Battery-Powered, Ophthalmic
HQA
Unit, Cryotherapy, Ophthalmic
HQB
Photocoagulator And Accessories
HQC
Unit, Phacofragmentation
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
HQF
Laser, Ophthalmic
HQO
Unit, Cautery, Thermal, Ac-Powered
HQP
Unit, Cautery, Thermal, Battery-Powered
HQQ
Apparatus, Cautery, Radiofrequency, Battery-Powered
HQR
Apparatus, Cautery, Radiofrequency, Ac-Powered
HQS
Burr, Corneal, Ac-Powered
HRF
Engine, Trephine, Accessories, Battery-Powered
HRG
Engine, Trephine, Accessories, Ac-Powered
HRH
Trephine, Manual, Ophthalmic
HRJ
Table, Instrument, Powered, Ophthalmic
HRK
Table, Instrument, Manual, Ophthalmic
HRN
Unit, Cryophthalmic, Ac-Powered
HRO
Unit, Electrolysis, Ac-Powered, Ophthalmic
HRP
Pen, Marking, Surgical
KYB
Lens, Guide, Intraocular
KYG
Device, Irrigation, Ocular Surgery
LCC
Applicator, Ocular Pressure
LPO
Gases Used Within Eye To Place Pressure On Detached Retina
LQJ
Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
LWL
Fluid, Intraocular
LXP
Plug, Scleral
LXS
Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
LZP
Aid, Surgical, Viscoelastic
P
22
0009
StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD)
P
20
0025
ClearVisc Ophthalmic Viscosurgical Device (OVD)
P
11
0007
HEALON ENDOCOAT OPVISCOSURGICAL OPHTHALMIC DEVICE (OVD) (3% SODIUM HYALURONATE)
P
00
0046
STAARVISC II
P
99
0023
CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE
P
96
0011
BIOLON 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID
P
89
0047
PROVISC(TM)VISCOELASTIC PREPARATION
P
88
0031
VITRAX SODIUM HYALURONATE
P
86
0047
HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML
P
82
0079
CDS II (SODIUM CHONDROITIN SULFATE)
P
81
0025
Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD)
P
20
0025
ClearVisc Ophthalmic Viscosurgical Device (OVD)
P
89
0047
PROVISC Ophthalmic Viscosurgical Device
P
84
0064
VISCOAT Ophthalmic Viscoelastic System, DUOVISC Ophthalmic Viscoelastic System (consists of PRIVSC and VISCOAT)
P
81
0025
Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD)
P
86
0047
OcuCoat OVD
P
81
0031
Healon PRO Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon Duet PRO Dual Pack, Healon GV PRO Sodium Hya
P
11
0007
Healon EndoCoat Ophthalmic Viscosurgical Device (3% Sodium Hyaluronate)
P
81
0031
Ophthalmic Viscoelastic Devices, Healon Duet Dual Pack and Healon Duet PRO Dual Pack
P
81
0031
Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD), Healon GV PRO
P
89
0047
PROVISC Ophthalmic Viscosurgical Device
P
84
0064
VISCOAT Ophthalmic Viscoelastic System, DUOVISC Ophthalmic Viscoelastic System (consists of PROVISC and VISCOAT), and DI
P
81
0025
Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD)
P
84
0064
VISCOAT Ophthalmic Viscoelastic System and DUOVISC Ophthalmic Viscoelastic System
P
89
0047
PROVISC Ophthalmic Viscosurgical Device
P
81
0031
Sodium Hyaluronate Ophtalmic Viscoelastic Devices (OVD), Healon Duet Dual Pack and Healon Duet PRO Dual Pack
P
11
0007
Healon EndoCoat Ophtalmic Viscosurgical Devices (OVD) (3% Sodium Hyaluronate)
P
84
0064
DUOVISC Ophthalmic Viscoelastic System (consists of PROVISC and VISCOAT), DISCOVISC Ophthalmic Viscosurgical Device
P
89
0047
PROVISC Ophthalmic Viscosurgical Device
P
00
0046
Ophthalmic Viscoelastic
P
96
0011
BIOLON
P
96
0011
BIOLON
P
81
0031
Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD)
P
84
0064
Ophthalmic Viscosurgical Devices
P
84
0064
VISCOAT/DUOVISC Ophthalmic Viscoelastic System
P
84
0064
VISCOAT Opthalmic Viscoelastic System, DUOVISC Opthalmic Viscoelastic System
P
89
0047
PROVISC Opthalmic Viscoelastic Device
P
96
0011
BIOLON
P
96
0011
BVI 1% OVD (formerly BD 1% OVD and Biolon)
P
81
0031
Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon, Healon GV, Healon5, Healon Ultimate Dual Pack, Healon
P
96
0011
BVI 1%OVD (fonnerly BD 1%OVD and Biolon)
P
96
0011
BVI 1% OVD (1% sodium hyaluronate viscoelastic surgical aid fluid)
P
84
0064
Duovisc, Viscoat, Discovisc Ophthalmic Viscosurgical Devices
P
89
0047
Provisc Ophthalmic Viscosurgical Devices
P
81
0031
HEALON DUET DUAL PACK
P
11
0007
HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD) (3% SODIUM HYALURONATE), MODEL VT585
P
84
0064
VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE; DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE (WITH PROVISC IN LATEX-FREE PACK)
P
89
0047
PROVISC Ophthalmic Viscosurgical Device (latex-ftee packaging configuration)
P
84
0064
OPHTHALMIC VICOSURGICAL DEVICE (OVD)
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
81
0031
Healon, Healo GV, Healon 5, Healon Ulrimate Dual Pack, Healon Duet Dual Pack products
P
81
0025
Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD)
P
86
0047
OcuCoat OVD
P
89
0047
PROVISC OVD
P
84
0064
Ophthalmic Viscosurgical Devices
P
00
0046
Ophthaalmic Viscoelastic
P
84
0064
VISCOAT, DISCOCISC Ophthalmic Viscosurgical Device
P
89
0047
PROVISC Ophthalmic Viscosurgical Devices
P
86
0047
OcuCoat OVD
P
81
0025
AMVISC & AMVISC PLUS OVD
P
81
0031
HEALON DUET DUAL PACK
P
11
0007
HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICES (OVD) (3% SODIUM HYALURONATE)
P
84
0064
DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES
P
81
0031
Healon Ultimate Dual Pack, HEALON, HEALON GV, HEALON5, and Healon Duet Dual Pack products
P
11
0007
HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD) (3% Sodium Hyaluronate)
P
99
0023
CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE
P
99
0023
CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, HEALON ULTIMATE DUAL PACK, AND HEALON DUET
P
84
0064
VISCOAT OPHTHALMIC VISCOSURGICAL DEVICES; DUOVISC OPTHALMIC VISCOSURGICAL DEVICES; DISCOVISC OPTHALMIC VISCOSURGICAL DEV
P
99
0023
CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
99
0023
CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
P
11
0007
HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICES (OVD), (3% SODIUM HYALURONATE)
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES-HEALON, HEALON GV, HEALON5 PRODUCTS, HEALON ULTIMATE DUAL PACK, AND H
P
86
0047
OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD)- HEALON5
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD)-HEALON, HEALON GV, HEALON5, AND HEALON ULTIMATE DUAL PACK
P
84
0064
VISCOAT & PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (LATEX-FREE PACKAGING CONFIGURATION ONLY FOR PROVISC)
P
89
0047
DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE (WITH PROVISC IN LATEX-FREE PACKAGING CONFIGURATION ONLY)
P
84
0064
VISCOAT OPHTHALMIC VISCOSURICAL DEVICE, DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5
P
11
0007
HEALON ENDOCOAT OPTHALMIC VISCOSURGICAL DEVICE
P
86
0047
OCUCOAT OVD
P
84
0064
DUOVISC AND DISCOVISC
P
89
0047
PROVISC
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
84
0064
VISCOAT,DUOVISC,DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5 PRODUCTS, HEALON ULTIMATE DUAL
P
81
0025
AMVISC AND AMVISC PLUS VISCOSURGICAL DEVICE
P
96
0011
BVI 1% OVD
P
00
0046
OPHTHALMICS- ANIKAVISC, OPTIVISC AND NUVISC
P
00
0046
STAARVISC, OPTIVISC AND ANIKAVISC SODIUM HYALURONATE
P
96
0011
BVI 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)
P
84
0064
VISCOAT, DUOVISC,DISCOVISC
P
89
0047
PROVISC
P
00
0046
NUVISC
P
86
0047
OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
P
99
0023
CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE (QVD)
P
00
0046
STAARVISC, OPTIVISC, AND ANIKAVISC SODIUM HYALURONATE
P
00
0046
STAARVISC II, SHELLGEL
P
96
0011
BVI 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES-HEALON, HEALON GV AND HEALON5
P
81
0025
AMVISC 0.8 ML SYRINGE AND AMVISC PLUS, O.8 ML SYRINGE
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
84
0064
DUOVISC & DISCOVISC OPTHALMIC VISCOSURGICAL DEVICES
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES(OVD), HEALON, HEALON GV AND HEALON5 PRODUCTS
P
84
0064
VISCOAT OPTHALMIC VISCOSURGICAL DEVICE; DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
11
0007
AMO HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD),(3% SODIUM HYALURONATE)
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES(OVD),HEALON,HEALONGV,AND HEALON5 PRODUCTS
P
96
0011
BVI 1%OVD
P
11
0007
HEALON ENDOCOAT OPHTHALMIC VISCOELASTIC DEVICES (OVD)
P
11
0007
HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
P
81
0025
AMVISC AND AMVISC PLUS OPHTHALMIC VISCOSURICAL DEVICE (OVD)
P
11
0007
AMO HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD) HEALON,HEALON GV, AND HEALON5 PRODUCTS
P
84
0064
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
89
0047
VISCOAT, DUROVISC AND DISCOVISC DEVICES OPHTHALMIC VISCOSURGICAL DEVICE
P
96
0011
BV1 1% OVD (1% SODIUM HYALURONATE VISCCOELASTIC SURGICAL AID FLUID)
P
86
0047
OCUCOAT HPMC VISCOELASTIC
P
81
0031
HEALON SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON ENDOCOAT OPHTHALMIC VISCOELASTIC DEVICE (OVD) (3
P
84
0064
VISCOAT AND DUOVISC OPHTHALMIC VISCOSURGICAL DEVICES (OVD)
P
11
0007
ABBOTT MEDICAL OPTICS (AMO) HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELEASTIC DEVICES (OVD) HEALON, HEALON GV AND HEALON5
P
86
0047
OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
P
81
0025
AMVISC AND AMVISC PLUS OPHTHALMIC VISCOSURGICAL DEVICE
P
81
0025
AMVISC/AMVISC PLUS OVDS
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
84
0064
DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
11
0007
HEALON ENDOCOAT OPVISCOSURGICAL OPHTHALMIC DEVICE (OVD) (3% SODIUM HYALURONATE)
P
81
0025
AMVISC & AMVISC PLUS
P
81
0025
AMVISC & AMVISC PLUS
P
86
0047
OCUCOAT (2% HYDROXPROPYLMETHYLCELLULOSE SOLUTION)
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5 PRODUCTS
P
96
0011
BVI 1% OVD (!% SODIUM HYALURONATE VICSCOELASTIC SURGICAL AID FLUID
P
00
0046
STAARVISC II & SHELLGEL SODIUM HYAURONATE
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
P
84
0064
DISCOVISC OPTHALMIC VISCOSURGICAL DEVICE (OVD) & DUOVISC VISCOELASTIC SYSTEM
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON 5 PRODUCTS
P
84
0064
DISCOVISC OPTHALMIC VISCOSURGICAL DEVICE (OVD)
P
89
0047
PROVISC OPTHALMIC VISCOSURGICAL DEVICE (OVD)
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, HEALON5
P
86
0047
OCUCOAT SYRINGE PRODUCT
P
84
0064
DISCOVISC OPTHALMIC VISCOSURGICAL DEVICE (OVD) & DUOVISC VISCOELASTIC SYSTEM
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
P
96
0011
BVI 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
84
0064
VISCOAT/DUOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES
P
81
0025
AMVISC & AMVISC PLUS (OPHTHALMIC VISCOSURGICAL DEVICES)
P
00
0046
STAARVISC II & SHELLGEL SODIUM HYALURONATE
P
00
0046
STAARVISC II, OPTIVISC/ANIKAVISC/SODIUM HYALURONATE
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV & HEALON 5 PRODUCTS
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD)
P
84
0064
VISCOAT/DISCOVISC/DUOVISC
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
99
0023
CELLUGEL
P
84
0064
DISCOVISC, VISCOAT AND DUOVISC
P
89
0047
PROVIS OPHTHALMIC VISCOSURGICAL DEVICE
P
96
0011
BVI 1% OVD-SODIUM HYALURONATE VISCOELASTIC
P
96
0011
BVI 1% OVD-SODIUM HYALURONATE VISCOELASTIC
P
00
0046
ANIKA VISC
P
00
0046
STAARVISC II & SHELLGEL SODIUM HYALURONATE
P
81
0025
AMVISC/AMVISC PLUS (OPHTHALMIC VISCOSURGICAL DEVICES)
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVOCES (OVD), HEALON GV, HEALON5 PRODUCTS
P
99
0023
CELLUGEL
P
84
0064
DISCOVISC, VISCOAT AND DUOVISC
P
89
0047
PROVISC
P
89
0047
PROVISC
P
84
0064
DISCOVISC/VISCOAT/DUOVISC
P
99
0023
CELLUGEL
P
89
0047
DISCOVISC, VISCOAT AND DUOVISC
P
84
0064
DISCOVISC, VISCOAT, AND DUOVISC
P
96
0011
BD 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
P
00
0046
OPTIVISC
P
96
0011
BD 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)
P
96
0011
BD 1% OVD ( 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)
P
96
0011
BD 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)
P
86
0047
OCUCOAT
P
99
0023
CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
84
0064
VISCOAT, DUOVISC & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
99
0023
CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
84
0064
VISCOAT/DUOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
84
0064
VISCOAT/DUOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
88
0031
HEALON D SODIUM HYALURONATE SOLUTION
P
99
0023
CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
84
0064
VISCOAT, DUOVISC, AND DISCOVIS OPHTHALMIC VISCOSURGICAL DEVICE
P
84
0064
DUOVISC VISCOELASTIC SYSTEM & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
99
0023
CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE
P
84
0064
VISCOAT, DUOVISC, DISCOVISC, PROVISC AND CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICES
P
81
0031
HEALON, HEALON GV/HEALON 5 SODIUM HYALURONATE OPHTHALMIC VISCOSURGICAL DEVICES
P
88
0031
VITRAX/HEALON D SODIUM HYALURONATE SOLUTION OPHTHALMIC VISCOSURGICAL DEVICES
P
88
0031
HEALON D
P
81
0031
HEALON, HEALON GV & HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
P
86
0047
OCUCOAT
P
86
0047
OCUCOAT
P
99
0023
CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE
P
84
0064
VISCOAT AND DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
86
0047
OCUCOAT
P
96
0011
BD OVD 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY
P
84
0064
VISCOAT, DUOVISC & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
84
0064
VISCOAT,DUOVISC & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
96
0011
BIOLON 1% SODIUM HYALURONATE
P
84
0064
VISCOAT, DUOVISC AND DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
81
0031
HEALON,HEALON GV, & HEALON5 SODIUM HYALURONATE VISCOELASTIC
P
81
0031
HEALON, HEALON GV AND HEALON5 SODIUM HYLAURONATE OPHTHALMIC VISCOELASTIC DEVICES
P
81
0031
HEALON SODIUM HYALURONATE VISCOELASTIC PRODUCTS
P
86
0047
OCUCOAT
P
96
0011
BD 1% OVD
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES ? HEALON, HEALON GV, AND HEALON5
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
P
81
0031
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
P
81
0031
HEALON,HEALON GV AND HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
P
81
0025
AMVISC & AMVISC PLUS
P
00
0046
STAARVISC II AND SHELLGEL SODIUM HYALURONATE
P
84
0064
VISCOAT, DUOVISC AND DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
81
0025
AMVISC AND AMVISC PLUS
P
00
0046
STAARVISC II, SHELLGEL AND COEASE
P
84
0064
DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
00
0046
STAARVISC II SODIUM HYALURONATE
P
84
0064
VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
P
96
0011
BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY
P
00
0046
SHELLGEL SODIUM HYALURONATE
P
84
0064
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE, PROVISC PACKAGED IN DUOVISC VISCOELASTIC SYSTEM AND DISCOVISC OPHTHALMIC VISCO
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
84
0064
DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
84
0064
DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
81
0031
HEALON SODIUM HYALURONATE VISCELASTIC PRODUCTS, HEALON,HEALON GV, HEALON 5
P
96
0011
BIOLON (1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY)
P
81
0025
AMVISC & AMVISC PLUS
P
00
0046
STAARVISC II, SHELLGEL, COEASE SODIUM HYALURONATE
P
86
0047
SILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT
P
81
0025
AMVISC TM & AMVISC TM PLUS
P
00
0046
STAARVISC II,SHELLGEL AND COEASE
P
86
0047
OCUCOAT, PMMA AND SILICONE INTRAOCULAR LENSES
P
99
0023
CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE
P
84
0064
DUOVISC VISCOELASTIC SYSTEM
P
89
0047
PROVISC OPHTHALMIC VICOSURGICAL DEVICE
P
81
0031
HEALON SODIUM HYALURONATE
P
86
0047
OCUCOAT (2% HYDROXYPROPYLMETHYLCELLULOSE SOLUTION)
P
99
0023
CELLUGEL OPHTHALMIC VISCOSURGICAL
P
81
0025
AMVISC & AMVISC PLUS
P
86
0047
OCUCOAT
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
84
0064
VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
P
00
0046
STAARVISC II, SHELLGEL AND COEASE
P
86
0047
OCUCOAT(2%HYDROXYPROPYLMETHLCELLULOSE SOLUTION)
P
86
0047
OCUCOAT(2%HYDROXYPROPYLMETHYLCELLULOSE SOLUTION)
P
00
0046
STAARVISC II, SHELLGEL AND COEASE SODIUM HYALURONATE VISCOELASTICS
P
00
0046
STAARVISC II, SHELLGEL AND COEASE SODIUM HYALURONATE VISCOELASTICS
P
00
0046
STAARVISC II,SHELLGEL AND COEASE VISCOELASTICS
P
81
0025
AMVISC AND AMVISC PLUS SODIUM HYALURONATE VISCOELASTICS
P
96
0011
BIOLON (1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY)
P
00
0046
STAARVISC II SODIUM HYALURONATE AND SHELLGEL SODIUM HYALURONATE
P
81
0031
HEALON SODIUM HYALURONATE
P
81
0025
AMVISC/AMVISC PLUS SODIUM HYALURONATE
P
00
0046
COEASE SODIUM HYALURONATE
P
96
0011
BIOLON(1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY)
P
84
0064
VISCOAT ORPHTHALMIC VISCOSURGICAL DEVICE
P
89
0047
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
P
00
0046
SHELLGEL(TM) SODIUM HYALURONATE
P
00
0046
STAARVISC II
P
96
0011
BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY
P
96
0011
BIOLON(TM) 1% SODIUM HYALURONATE
P
84
0064
VISCOAT(R) SODIUM HYALURONATE
P
89
0047
DUOVISC LABELING INSERT FOR PROVISC(R) SODIUM HYALURONATE PMA
P
81
0031
HEALON 5 SODIUM HYALURONATE
P
96
0011
BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY
P
99
0023
CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE
P
99
0023
CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE
P
81
0031
HEALON(R) SODIUM HYALURONATE
P
88
0031
AMO VITRAX (SODIUM HYALURONATE) VISCOELASTIC SOLUTION
P
96
0011
BIOLON 1% SODIUM HYALURONATE
P
96
0011
BIOLON TM
P
96
0011
BIOLON 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID
P
96
0011
BIOLON 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID
P
84
0064
VISCOAT(R) VISCOELASTIC SOLUTION
P
84
0064
VISCOAT VISCOELASTIC SOLUTION
P
89
0047
PROVISC VISCOELASTIC MATERIAL
P
84
0064
VISCOAT(R)
P
88
0031
AMO(R) VITRAX(R) VISCOELASTIC SOLUTION
P
88
0031
AMO(R) VITRAX(R) VISCOELASTIC SOLUTION
P
86
0047
OCUCOAT (2% HYDROXYPROPYLMETHYLCELLULOSE SOLUTION)
P
89
0047
PROVISC VISCOELASTIC MATERIAL
P
84
0064
VISCOAT VISCOELASTIC SOLUTION
P
88
0031
AMO(R) VITRAX(R) VISCOELASTIC SOLUTION
P
88
0031
AMO VITRAX (SODIUM HYALURONATE)
P
84
0064
DUOVISC VISCOELASTIC SYSTEM
P
89
0047
DUOVISC VISCOELASTIC SYSTEM
P
84
0064
VISCOAT VISCOELASTIC SYSTEM
P
89
0047
DUOVISC VISCOELASTIC SYSTEM
P
89
0047
DUOVISC VISCOELASTIC SYSTEM
P
84
0064
DUOVISC VISCOELASTIC SYSTEM
P
86
0047
OCUCOAT (2% HYDROXYPROPYLMETHYLCELLULOSE)
P
86
0047
HYDROXYPROPYLMETHYLCELLULOSE 2% OCCUCOAT (R)
P
81
0031
HEALON(R) VISCOELASTIC PRODUCTS
P
84
0064
VISCOAT(TM)
P
89
0047
PROVISC TM VISCOELASTIC PREPARATION
P
81
0025
AMVISC (R)
P
81
0031
HEALON(R) VISCOELASTIC PRODUCTS
P
89
0047
PROVISC TM VISCOELASTIC PREPARATION
P
86
0047
HYDROXYPROPYLMETHYLCELLULOSE 2% OCCUCOAT (R)
P
89
0047
PROVISC TM VISCOELASTIC PREPARATION
P
84
0064
VISCOAT(TM)
P
88
0031
AMO(R) VITRAX(R) VISCOELASTIC SOLUTION
P
86
0047
HYDROXYPROPYLMETHYLCELLULOSE 2% OCCUCOAT (R)
P
89
0047
PROVISC TM VISCOELASTIC PREPARATION
P
81
0031
HEALON GV(TM)
P
88
0031
VITRAX OPHTHALMIC SURGICAL AID
P
88
0031
VITRAX OPHTHALMIC SURGICAL AID
P
88
0031
VITRAX OPHTHALMIC SURGICAL AID
P
89
0047
PROVISC TM VISCOELASTIC PREPARATION
P
86
0047
HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML, DGR,INC.
P
86
0047
HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML, MDR CORP.
P
86
0047
HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML, WORLD OPTICS
P
81
0031
HEALON(R)
P
88
0031
VITRAX OPHTHALMIC SURGICAL AID
P
81
0031
HEALON
P
89
0047
PROVISC(TM)VISCOELASTIC PREPARATION
P
90
0010
ORCOLON (R) (POLYACRYLAMIDE)
P
90
0010
ORCOLON (R) (POLYACRYLAMIDE)
P
86
0047
HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML
P
84
0064
VISCOAT(TM)
P
84
0064
VISCOAT(TM)
P
84
0064
VISCOAT(TM)
P
84
0064
VISCOAT(TM)
P
86
0047
HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML
P
81
0025
AMVISC (R)
P
81
0031
HEALON
P
88
0031
VITRAX SODIUM HYALURONATE
P
81
0025
AMVISC (R)
P
81
0031
HEALON
P
81
0025
AMVISC (R)
P
86
0047
HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML
P
81
0025
AMVISC (R)
P
81
0025
AMVISC (R)
P
81
0025
AMVISC (R)
P
84
0064
VISCOAT(TM)
P
84
0064
VISCOAT(TM)
P
84
0064
VISCOAT(TM)
P
81
0025
AMVISC (R)
P
81
0025
HYVISC(R)
P
81
0031
HEALON
P
84
0064
VISCOAT(TM)
P
84
0064
VISCOAT(TM)
P
84
0064
VISCOAT(TM)
P
82
0079
CDS II (SODIUM CHONDROITIN SULFATE)
P
81
0031
HEALON
P
81
0025
AMVISC(TM)
P
84
0064
VISCOAT(TM)/DVOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES
P
81
0031
HEALON
P
81
0025
HYVISC(R)
P
81
0025
HYVISC(R)
P
81
0031
HEALON
P
81
0031
HEALON
P
81
0031
HEALON
P
81
0025
HYVISC(R)
P
81
0031
HEALON
P
81
0031
HEALON
P
81
0025
AMVISC(R)
P
81
0031
HEALON, HEALON GV, HEALON5 PRODUCTS SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
MLZ
Vitrectomy, Instrument Cutter
MMC
Dilator, Expansive Iris (Accessory)
MOE
Collagen Corneal Shield
MSR
Tubing, Replacement, Phacofragmentation Unit
MSS
Folders And Injectors, Intraocular Lens (Iol)
MUS
Fluidic, Phacoemulsification/Phacofragmentation
MXO
Laser, System, Phacolysis
MXY
Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal
MYD
Keratome, Water Jet
NCE
Injector, Capsular Tension Ring
NCR
Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered
NGY
Cannula, Trocar, Ophthalmic
NKX
Needle, Phacoemulsification, Reprocessed
NKY
Blade, Keratome, Reprocessed
NLA
Knife, Ophthalmic, Reprocessed
NVB
Intraocular, Pressure Measuring Device
OHW
Burr, Corneal, Battery Powered, Rust Ring Removal
OHX
Burr, Corneal, Ac-Powered, Rust Ring Removal
OJK
Eye Tray
OOE
Ophthalmic Femtosecond Laser
OTZ
Graft Insertion Instrument For Endothelial Keratoplasty
PUL
Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered
PZG
Surgical Eye Tray
QDV
Iol Tray
QDW
Phaco Kit
QDY
Vitrectomy Kit
QGJ
Corneal Inlay Inserter Handle
QQQ
Guide And Positioner, Ophthalmic Drug Delivery Device
PYU
Sponge, Eyelid Cleaning, Powered
QUQ
Knife, Intraocular Pressure Lowering
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
/
subpart-e—surgical-devices
/
LZP
/
P840064
View Source
VISCOAT Ophthalmic Viscoelastic System, DUOVISC Ophthalmic Viscoelastic System (consists of PRIVSC and VISCOAT)
Page Type
PMA Approval
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
ALCON LABORATORIES
Trade Name
VISCOAT(TM)/DVOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES
Generic Name
AID, SURGICAL, VISCOELASTIC
Decision Date
4/30/1986
Days to Decision
517 days
Decision Code
APPR
FDA Decision
Approval