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
Jan 02, 2013
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS
MRC
Products, Contact Lens Care, Rigid Gas Permeable
156d
Cleared
Dec 31, 2012
LIPIVIEW OCULAR SURFACE INTERFEROMETER
HKI
Camera, Ophthalmic, Ac-powered
139d
Cleared
Dec 21, 2012
CENTURION VISION SYSTEM
HQC
Unit, Phacofragmentation
210d
Cleared
Dec 20, 2012
PANOPTIC
HKI
Camera, Ophthalmic, Ac-powered
224d
Cleared
Dec 20, 2012
BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI
LPL
Lenses, Soft Contact, Daily Wear
119d
Cleared
Dec 17, 2012
LACRIFAST
OKS
Lacrimal Stents And Intubation Sets
269d
Cleared
Dec 12, 2012
ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
140d
Cleared
Dec 12, 2012
LENSX LASER SYSTEM
OOE
Ophthalmic Femtosecond Laser
70d
Cleared
Dec 03, 2012
LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS
HQC
Unit, Phacofragmentation
77d
Cleared
Nov 26, 2012
POLARIS DIAL-A-DATE CONTACT LENS CASE
LRX
Case, Contact Lens
245d
Cleared
Nov 13, 2012
PASCAL LASER INDIRECT OPHTHALMOSCOPE
HQF
Laser, Ophthalmic
43d
Cleared
Nov 08, 2012
CORVIS ST
HKX
Tonometer, Ac-powered
388d
Cleared
Nov 08, 2012
DCS LACRIMAL STENT
OKS
Lacrimal Stents And Intubation Sets
365d
Cleared
Nov 02, 2012
FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH
NFJ
System, Image Management, Ophthalmic
39d
Cleared
Oct 26, 2012
SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
190d
Cleared
Oct 25, 2012
SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT
OBO
Tomography, Optical Coherence
111d
Cleared
Oct 19, 2012
LACRICATH LACRIMAL DUCT CATHETER
OKS
Lacrimal Stents And Intubation Sets
294d
Cleared
Oct 15, 2012
LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)
HQC
Unit, Phacofragmentation
125d
Cleared
Oct 05, 2012
CVUE ADVANCED HYDRA VUE
LPL
Lenses, Soft Contact, Daily Wear
122d
Cleared
Oct 03, 2012
EK DELIVERY DEVICE
OTZ
Graft Insertion Instrument For Endothelial Keratoplasty
126d
Cleared
Sep 28, 2012
BAUSCH & LOMB IOL INJECTOR
MSS
Folders And Injectors, Intraocular Lens (iol)
274d
Cleared
Sep 28, 2012
DIGITAL EYE-FUNDUS CAMERA
HKI
Camera, Ophthalmic, Ac-powered
179d
Cleared
Sep 18, 2012
ISIGHT
LPL
Lenses, Soft Contact, Daily Wear
119d
Cleared
Sep 17, 2012
KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES
HQF
Laser, Ophthalmic
151d
Cleared
Sep 14, 2012
SUPRA SCAN DELIVERY SYSTEM
HQF
Laser, Ophthalmic
179d
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