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
2887 Ophthalmic devices
Cleared
Nov 06, 2006
CRYOMATIC
HRN
Unit, Cryophthalmic, Ac-powered
81d
Cleared
Nov 01, 2006
KOWA VX-10I
HKI
Camera, Ophthalmic, Ac-powered
107d
Cleared
Nov 01, 2006
MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
HQD
Lens, Contact (other Material) - Daily
63d
Cleared
Nov 01, 2006
VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY)
LPL
Lenses, Soft Contact, Daily Wear
57d
Cleared
Oct 31, 2006
HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT
OBO
Tomography, Optical Coherence
11d
Cleared
Oct 20, 2006
IRI INTEGRATED RETINAL IMAGER
HKI
Camera, Ophthalmic, Ac-powered
74d
Cleared
Oct 13, 2006
XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII
MPA
Endoilluminator
16d
Cleared
Oct 06, 2006
RTVUE
OBO
Tomography, Optical Coherence
37d
Cleared
Sep 28, 2006
MP-1 MICROPERIMETER
HKI
Camera, Ophthalmic, Ac-powered
97d
Cleared
Sep 27, 2006
MOLTENO3
KYF
Implant, Eye Valve
55d
Cleared
Sep 27, 2006
KOWA NONMYD ALPHA-D
HKI
Camera, Ophthalmic, Ac-powered
44d
Cleared
Sep 18, 2006
AHMED GLAUCOMA VALVE, MODEL M4
KYF
Implant, Eye Valve
192d
Cleared
Sep 06, 2006
ZYOPTIX XP EPI SEPARATOR SYSTEM
HNO
Keratome, Ac-powered
13d
Cleared
Aug 23, 2006
RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER
HLI
Ophthalmoscope, Ac-powered
70d
Cleared
Aug 15, 2006
ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100
MPA
Endoilluminator
11d
Cleared
Aug 08, 2006
ORBITAL TISSUE EXPANDER (OTE)
NFM
Expander, Tissue, Orbital
200d
Cleared
Aug 07, 2006
MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE
OKS
Lacrimal Stents And Intubation Sets
80d
Cleared
Jul 11, 2006
SNUG PLUG PUNCTUM PLUG
LZU
Plug, Punctum
53d
Cleared
Jun 28, 2006
JSZ MULTIACTION GP CONTACT LENS SOLUTION
LPN
Accessories, Soft Lens Products
85d
Cleared
Jun 22, 2006
SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENSES
HQD
Lens, Contact (other Material) - Daily
62d
Cleared
Jun 22, 2006
SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
MVN
Lens, Contact, (disposable)
57d
Cleared
Jun 21, 2006
PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60
HQF
Laser, Ophthalmic
69d
Cleared
Jun 09, 2006
KOWA KT-800
HKX
Tonometer, Ac-powered
182d
Cleared
May 31, 2006
EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION
LPN
Accessories, Soft Lens Products
394d
Cleared
May 25, 2006
PSL PORTABLE SLIT LAMP
HJO
Biomicroscope, Slit-lamp, Ac-powered
13d
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