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
5110
Total
5092
Cleared
168d
Avg (2y)
1976
Since
2884 Ophthalmic devices
Cleared
Mar 11, 2014
KOWA SL-17
HJO
Biomicroscope, Slit-lamp, Ac-powered
92d
Cleared
Mar 07, 2014
HEINE MINI 3000(R) OPHTHALMOSCOPE
HLJ
Ophthalmoscope, Battery-powered
253d
Cleared
Mar 05, 2014
ISENS (POLYMACON) SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (CLEAR, TINTED, AND COSMETIC TINTED)
LPL
Lenses, Soft Contact, Daily Wear
187d
Cleared
Mar 05, 2014
SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULTIFOCAL WITH TINT
LPL
Lenses, Soft Contact, Daily Wear
86d
Cleared
Mar 04, 2014
SAUFLON CLARITI 1 DAY WITH TINT (TORIC/MULTIFOCAL)
LPL
Lenses, Soft Contact, Daily Wear
112d
Cleared
Feb 27, 2014
COMPACT INTUITIV
HQC
Unit, Phacofragmentation
150d
Cleared
Feb 21, 2014
POLAROID CONTACTSPOD
LRX
Case, Contact Lens
249d
Cleared
Feb 21, 2014
T-TYPE D-KAT, R-TYPE D-KAT
HKY
Tonometer, Manual
123d
Cleared
Feb 19, 2014
RS-3000 ADVANCE
OBO
Tomography, Optical Coherence
209d
Cleared
Feb 14, 2014
VICTUS FEMTOSECOND LASER PLATFORM
OOE
Ophthalmic Femtosecond Laser
185d
Cleared
Feb 14, 2014
STELLARIS VISION ENHANCEMENT SYSTEM
HQC
Unit, Phacofragmentation
116d
Cleared
Feb 12, 2014
OWL CONTACT LENS CASES, DOG CONTACT LENS CASES
LRX
Case, Contact Lens
314d
Cleared
Feb 12, 2014
SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION
HJO
Biomicroscope, Slit-lamp, Ac-powered
92d
Cleared
Jan 29, 2014
AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL
LPL
Lenses, Soft Contact, Daily Wear
104d
Cleared
Jan 09, 2014
BAUSCH & LOMB INJECTOR SYSTEM
MSS
Folders And Injectors, Intraocular Lens (iol)
196d
Cleared
Jan 03, 2014
BAUSCH + LUMB, VIS100 INJECTOR SYSTEM
MSS
Folders And Injectors, Intraocular Lens (iol)
78d
Cleared
Dec 27, 2013
EASY-LOAD LENS DELIVERY SYSTEM
MSS
Folders And Injectors, Intraocular Lens (iol)
141d
Cleared
Dec 23, 2013
CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES
HRN
Unit, Cryophthalmic, Ac-powered
188d
Cleared
Dec 23, 2013
EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
102d
Cleared
Dec 23, 2013
LIPIFLOW THERMAL PULSATION SYSTEM
ORZ
Eyelid Thermal Pulsation System
84d
Cleared
Dec 23, 2013
AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
27d
Cleared
Dec 20, 2013
BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
112d
Cleared
Dec 20, 2013
OCULAR FORCE GAUGE
HKY
Tonometer, Manual
94d
Cleared
Dec 18, 2013
OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2
HKI
Camera, Ophthalmic, Ac-powered
156d
Cleared
Dec 17, 2013
IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC)
LPL
Lenses, Soft Contact, Daily Wear
78d
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