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
Sep 06, 2012
LENSSX LASER SYSTEM
HQC
Unit, Phacofragmentation
181d
Cleared
Aug 31, 2012
DACRYOCATH
OKS
Lacrimal Stents And Intubation Sets
277d
Cleared
Aug 28, 2012
CATALYS PRECISION LASER SYSTEM
OOE
Ophthalmic Femtosecond Laser
140d
Cleared
Aug 23, 2012
AVT NATURASOFT
LPL
Lenses, Soft Contact, Daily Wear
113d
Cleared
Aug 20, 2012
OPTO HYALUS GREEN LASER
HQF
Laser, Ophthalmic
452d
Cleared
Aug 17, 2012
CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION
LPL
Lenses, Soft Contact, Daily Wear
366d
Cleared
Aug 09, 2012
CRAWFORD BIOCANALICULUS INTUBATION
OKS
Lacrimal Stents And Intubation Sets
115d
Cleared
Aug 03, 2012
MASTERKA 40 MASTERKA 35 MASTERKA 30
OKS
Lacrimal Stents And Intubation Sets
247d
Cleared
Jul 31, 2012
STENTUBE LACRIMAL INTUBATION SET
OKS
Lacrimal Stents And Intubation Sets
284d
Cleared
Jul 31, 2012
VICTUS LASER PLATFORM
OOE
Ophthalmic Femtosecond Laser
169d
Cleared
Jul 20, 2012
CAUTERY
HQP
Unit, Cautery, Thermal, Battery-powered
66d
Cleared
Jul 11, 2012
AC LENS BRANDED CONTACT LENS CASE
LRX
Case, Contact Lens
103d
Cleared
Jul 06, 2012
SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE
LRX
Case, Contact Lens
92d
Cleared
Jun 28, 2012
FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN
HQD
Lens, Contact (other Material) - Daily
87d
Cleared
Jun 21, 2012
VERSAVIT
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
15d
Cleared
Jun 18, 2012
CIRRUS PHOTO
OBO
Tomography, Optical Coherence
326d
Cleared
Jun 15, 2012
INFINITI(R) VISION SYSTEM
HQC
Unit, Phacofragmentation
81d
Cleared
Jun 08, 2012
TBD
OOE
Ophthalmic Femtosecond Laser
136d
Cleared
Jun 05, 2012
BAUSCH + LOMB NESOFILCON A CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
172d
Cleared
May 31, 2012
NCI SPATULA
OTZ
Graft Insertion Instrument For Endothelial Keratoplasty
442d
Cleared
May 30, 2012
PROCARE PLUS VITRECTOMY SYSTEM
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
132d
Cleared
May 25, 2012
OPTOS ADVANCE
NFJ
System, Image Management, Ophthalmic
161d
Cleared
May 11, 2012
ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)
HLI
Ophthalmoscope, Ac-powered
123d
Cleared
May 10, 2012
ILWAIT TIMER OCULOPRESSOR
LCC
Applicator, Ocular Pressure
218d
Cleared
May 08, 2012
NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX
HKI
Camera, Ophthalmic, Ac-powered
169d
Looking for a specific ophthalmic device? Search by device name, K-number or manufacturer.
Search all Ophthalmic 510(k) devices