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FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Diagnostic Devices
CFR Sub-Part
General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Miscellaneous
Miscellaneous
Prosthetic Devices
CFR Sub-Part
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
K
13
2796
SUNTOUCH EYE SPEAR
2
Cleared 510(K)
K
13
0117
NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS
2
Cleared 510(K)
K
09
1240
ALPHAMED SURGICAL SPEAR, MODEL 70-5000
2
Cleared 510(K)
K
08
2460
CENEFOM PVA SURGICAL SPEAR
2
Cleared 510(K)
K
01
2196
ULTRACELL ABSORBENT STICK
2
Cleared 510(K)
K
01
1191
MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
2
Cleared 510(K)
K
00
3842
PRESCOTT'S SURGICAL SPEAR
2
Cleared 510(K)
K
00
2279
ML EYE SPEAR, MODEL ML 27 ES
2
Cleared 510(K)
K
99
3883
M-PACT CORNEAL LIGHT SHIELD
2
Cleared 510(K)
K
99
0671
DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE
2
Cleared 510(K)
K
99
0749
SOF-SUCTION FLUID EVACUATION SYSTEM
2
Cleared 510(K)
K
98
2599
THE FREMSTAD RING
2
Cleared 510(K)
K
97
4313
HYDROFERA SURGICAL SPEAR
2
Cleared 510(K)
K
97
2633
ULTRACELL SUCTION SPONGE
2
Cleared 510(K)
K
97
2693
DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR
2
Cleared 510(K)
K
97
1832
IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK
2
Cleared 510(K)
K
96
4855
EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD
2
Cleared 510(K)
K
94
6016
IVALON OPHTHALMIC SPONGE
2
Cleared 510(K)
K
95
0241
OPHTHALMIC SPONGES
2
Cleared 510(K)
K
94
2642
SURGI-WIPE
2
Cleared 510(K)
K
93
3872
VISI-SPEAR EYE SPONGE
2
Cleared 510(K)
K
92
3922
SURGICAL SPEARS
2
Cleared 510(K)
K
92
0354
OPHTHALMIC SPONGES
2
Cleared 510(K)
K
91
0707
OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS
2
Cleared 510(K)
K
90
2750
VISI-SWAB OPHTALMIC SPONGE
2
Cleared 510(K)
K
90
0786
VISI-SORB ABSORBANT STICK
2
Cleared 510(K)
K
89
7034
K-SPONGE
2
Cleared 510(K)
K
89
6705
VISITEC MICRO-SPONGE SPEARS
2
Cleared 510(K)
K
89
6084
MICROSPEARS
2
Cleared 510(K)
K
89
6004
ALCON SURGICAL SPONGE
2
Cleared 510(K)
K
88
5232
FLUID DRAINAGE WICK
2
Cleared 510(K)
K
87
2612
SOLOS EYESITE SPONGES
2
Cleared 510(K)
K
85
2055
ASCON OPHTHALMIC SPONGE
2
Cleared 510(K)
K
85
0340
EYE PROCEDURE PACK
2
Cleared 510(K)
K
84
2983
AMPCO OPTHALMIC TRAY
2
Cleared 510(K)
K
84
2601
PRE-OPERATIVE OPHTHALMIC DRESSING TRAY
2
Cleared 510(K)
K
84
2990
STERILE EYE SURGERY KITS
2
Cleared 510(K)
K
85
0050
PMS OPHTHALMOLOGY PACK-PMS EYE TRAY/PACK
2
Cleared 510(K)
K
85
0883
SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11
2
Cleared 510(K)
K
84
1721
OPERAID SURGICAL DRAIN
2
Cleared 510(K)
K
84
0471
EYE SPEAR
2
Cleared 510(K)
K
83
4356
EYE SPONGE OR SPEAR
2
Cleared 510(K)
K
83
0262
FLORET OPHTHALMIC EYE SPEAR
2
Cleared 510(K)
K
80
2794
PRO-OPHTA STICKS
2
Cleared 510(K)
K
78
0987
SOFT SILICONE ELASTOMER SPONGE EXPLANT
2
Cleared 510(K)
K
78
0257
MICROSPEARS
2
Cleared 510(K)
K
76
1155
CELLULOSE EYE STICK
2
Cleared 510(K)
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
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
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 2 June 2023 at 11:04 pm
OP
/
surgical-devices
/
HOZ
/
K872612
View Source
SOLOS EYESITE SPONGES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K872612
510(k) Type
Traditional
Applicant
SOLOS OPHTHALMOLOGY
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/31/1987
Days to Decision
25 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Diagnostic Devices
General Hospital and Personal Use Therapeutic Devices
Miscellaneous
Prosthetic Devices
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
K
13
2796
SUNTOUCH EYE SPEAR
K
13
0117
NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS
K
09
1240
ALPHAMED SURGICAL SPEAR, MODEL 70-5000
K
08
2460
CENEFOM PVA SURGICAL SPEAR
K
01
2196
ULTRACELL ABSORBENT STICK
K
01
1191
MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
K
00
3842
PRESCOTT'S SURGICAL SPEAR
K
00
2279
ML EYE SPEAR, MODEL ML 27 ES
K
99
3883
M-PACT CORNEAL LIGHT SHIELD
K
99
0671
DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE
K
99
0749
SOF-SUCTION FLUID EVACUATION SYSTEM
K
98
2599
THE FREMSTAD RING
K
97
4313
HYDROFERA SURGICAL SPEAR
K
97
2633
ULTRACELL SUCTION SPONGE
K
97
2693
DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR
K
97
1832
IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK
K
96
4855
EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD
K
94
6016
IVALON OPHTHALMIC SPONGE
K
95
0241
OPHTHALMIC SPONGES
K
94
2642
SURGI-WIPE
K
93
3872
VISI-SPEAR EYE SPONGE
K
92
3922
SURGICAL SPEARS
K
92
0354
OPHTHALMIC SPONGES
K
91
0707
OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS
K
90
2750
VISI-SWAB OPHTALMIC SPONGE
K
90
0786
VISI-SORB ABSORBANT STICK
K
89
7034
K-SPONGE
K
89
6705
VISITEC MICRO-SPONGE SPEARS
K
89
6084
MICROSPEARS
K
89
6004
ALCON SURGICAL SPONGE
K
88
5232
FLUID DRAINAGE WICK
K
87
2612
SOLOS EYESITE SPONGES
K
85
2055
ASCON OPHTHALMIC SPONGE
K
85
0340
EYE PROCEDURE PACK
K
84
2983
AMPCO OPTHALMIC TRAY
K
84
2601
PRE-OPERATIVE OPHTHALMIC DRESSING TRAY
K
84
2990
STERILE EYE SURGERY KITS
K
85
0050
PMS OPHTHALMOLOGY PACK-PMS EYE TRAY/PACK
K
85
0883
SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11
K
84
1721
OPERAID SURGICAL DRAIN
K
84
0471
EYE SPEAR
K
83
4356
EYE SPONGE OR SPEAR
K
83
0262
FLORET OPHTHALMIC EYE SPEAR
K
80
2794
PRO-OPHTA STICKS
K
78
0987
SOFT SILICONE ELASTOMER SPONGE EXPLANT
K
78
0257
MICROSPEARS
K
76
1155
CELLULOSE EYE STICK
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
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
Therapeutic Devices
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OP
/
surgical-devices
/
HOZ
/
K872612
View Source
SOLOS EYESITE SPONGES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K872612
510(k) Type
Traditional
Applicant
SOLOS OPHTHALMOLOGY
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/31/1987
Days to Decision
25 days