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
2885 Ophthalmic devices
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
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
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