FDA 510(k) Ophthalmic Devices
FDA 510(k) Ophthalmic Devices - Regulatory Overview
FDA 510(k) ophthalmic devices include diagnostic and surgical equipment for eye care. The FDA review panel code is OP.
Main categories:
- Contact lenses - daily, extended wear, toric and multifocal lenses
- Intraocular lenses (IOLs) - monofocal, toric and premium IOLs for cataract surgery
- Ophthalmic lasers - excimer lasers for LASIK, Nd:YAG, photocoagulation
- Retinal imaging systems - OCT, fundus cameras, fluorescein angiography
- Diagnostic instruments - tonometers, perimeters, autorefractors, slit lamps
5119
Total
5101
Cleared
169d
Avg (2y)
1976
Since
5119 Ophthalmic devices
Cleared
Oct 02, 2001
ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626
NGY
Cannula, Trocar, Ophthalmic
63d
Cleared
Sep 26, 2001
FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM
HKI
Camera, Ophthalmic, Ac-powered
103d
Cleared
Sep 26, 2001
THE INTUITIVE COLORIMETER
NFD
Selector, Color, Spectacle, Lens, Tint
68d
Cleared
Sep 12, 2001
RIGID GAS PERMEABLE CONTACT LENS SOLUTION
HQD
Lens, Contact (other Material) - Daily
83d
Cleared
Aug 31, 2001
AA-1 SYSTEM
HJT
Haploscope
25d
Cleared
Aug 24, 2001
GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
137d
Cleared
Aug 24, 2001
DISPOSABLE VITRECTOMY LENS
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
50d
Cleared
Aug 24, 2001
ULTRACELL ABSORBENT STICK
HOZ
Sponge, Ophthalmic
42d
Cleared
Aug 22, 2001
LIGHTLAS 532 PHOTOCOAGULATOR
HQF
Laser, Ophthalmic
196d
Cleared
Aug 13, 2001
OSMED TISSUE EXPANDER
NFM
Expander, Tissue, Orbital
145d
Cleared
Aug 01, 2001
THE ALBERTA LENS SM2, SULFOCON B
HQD
Lens, Contact (other Material) - Daily
167d
Cleared
Jul 27, 2001
HYDRO2, HS-75
HQD
Lens, Contact (other Material) - Daily
38d
Cleared
Jul 25, 2001
BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT
MVN
Lens, Contact, (disposable)
51d
Cleared
Jul 17, 2001
TORIC LITE LENS
LPL
Lenses, Soft Contact, Daily Wear
84d
Cleared
Jul 17, 2001
DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES
MRC
Products, Contact Lens Care, Rigid Gas Permeable
67d
Cleared
Jul 09, 2001
S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY-
LPL
Lenses, Soft Contact, Daily Wear
377d
Cleared
Jul 09, 2001
S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED, FULLY-
LPL
Lenses, Soft Contact, Daily Wear
363d
Cleared
Jul 09, 2001
EASY CONTROL MICRO INSERTER, MODEL ON385
NCE
Injector, Capsular Tension Ring
55d
Cleared
Jul 02, 2001
PROVIEW EYE PRESSURE MONITOR
HKY
Tonometer, Manual
74d
Cleared
Jul 02, 2001
CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000)
MML
Weights, Eyelid, External
27d
Cleared
Jun 27, 2001
LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201
HKX
Tonometer, Ac-powered
85d
Cleared
Jun 26, 2001
MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
HOZ
Sponge, Ophthalmic
68d
Cleared
Jun 26, 2001
SPECIALTY D-UV (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY D-UV MULTIFOCAL (OCUFLICON D)
LPL
Lenses, Soft Contact, Daily Wear
39d
Cleared
Jun 22, 2001
ML BLADE, MODEL ML7030
HNO
Keratome, Ac-powered
91d
Cleared
Jun 19, 2001
MEDPOR QUAD MOTILITY IMPLANT
HPZ
Implant, Eye Sphere
85d
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