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
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
Cleared
Dec 04, 2013
SELF-RETAINING BICANALICULUS INTUBATON SET II
OKS
Lacrimal Stents And Intubation Sets
293d
Cleared
Dec 04, 2013
HEINE BETA 200(R) OPHTHALMOSCOPE
HLJ
Ophthalmoscope, Battery-powered
160d
Cleared
Nov 27, 2013
SPECULAR MICROSCOPE CEM-530
NQE
Microscope, Specular
268d
Cleared
Nov 14, 2013
PEREGRINE CURVED ILLUMINATING LASER PROBE
HQB
Photocoagulator And Accessories
85d
Cleared
Nov 01, 2013
SCANNING LASERLINK
HQF
Laser, Ophthalmic
277d
Cleared
Oct 30, 2013
OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS
HLJ
Ophthalmoscope, Battery-powered
140d
Cleared
Oct 30, 2013
SUNTOUCH EYE SPEAR
HOZ
Sponge, Ophthalmic
54d
Cleared
Oct 29, 2013
NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS
HOZ
Sponge, Ophthalmic
286d
Cleared
Oct 22, 2013
VISCOELASTIC INJECTOR
MRH
Pump, Infusion, Ophthalmic
74d
Cleared
Oct 18, 2013
LENSTEC LC INJECTION SYSTEM
MSS
Folders And Injectors, Intraocular Lens (iol)
395d
Cleared
Oct 17, 2013
IMAGENET 5 PC SOFTWARE SYSTEM
NFJ
System, Image Management, Ophthalmic
73d
Cleared
Oct 09, 2013
FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER
HQF
Laser, Ophthalmic
163d
Cleared
Oct 09, 2013
SYNERGY ODM
NFJ
System, Image Management, Ophthalmic
43d
Cleared
Sep 26, 2013
LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM
HQF
Laser, Ophthalmic
272d
Cleared
Sep 17, 2013
CRYSTALSERT DELIVERY SYSTEM
MSS
Folders And Injectors, Intraocular Lens (iol)
29d
Cleared
Sep 11, 2013
BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,
LPL
Lenses, Soft Contact, Daily Wear
135d
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