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
Apr 06, 2017
Huvitz Imaging System
NFJ
System, Image Management, Ophthalmic
275d
Cleared
Apr 06, 2017
IOLMaster 700
HJO
Biomicroscope, Slit-lamp, Ac-powered
77d
Cleared
Mar 24, 2017
Stellaris Elite Vision Enhancement System
HQC
Unit, Phacofragmentation
214d
Cleared
Mar 24, 2017
Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens
HQD
Lens, Contact (other Material) - Daily
50d
Cleared
Mar 22, 2017
HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+
MLZ
Vitrectomy, Instrument Cutter
28d
Cleared
Mar 21, 2017
Icare HOME tonometer
HKY
Tonometer, Manual
112d
Cleared
Mar 03, 2017
3D OCT-1 Maestro
OBO
Tomography, Optical Coherence
44d
Cleared
Feb 23, 2017
VISULUX
HJO
Biomicroscope, Slit-lamp, Ac-powered
258d
Cleared
Feb 16, 2017
SLIT LAMP, Model: YF-100
HJO
Biomicroscope, Slit-lamp, Ac-powered
234d
Cleared
Feb 08, 2017
OptosAdvance 4.0 Software
NFJ
System, Image Management, Ophthalmic
201d
Cleared
Feb 03, 2017
LenSx Laser System
OOE
Ophthalmic Femtosecond Laser
46d
Cleared
Jan 23, 2017
D.O.R.C. Disposable Cryo Probe
HRN
Unit, Cryophthalmic, Ac-powered
328d
Cleared
Jan 18, 2017
Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens
HQD
Lens, Contact (other Material) - Daily
58d
Cleared
Jan 04, 2017
Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)
LPL
Lenses, Soft Contact, Daily Wear
149d
Cleared
Dec 19, 2016
Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
LPL
Lenses, Soft Contact, Daily Wear
178d
Cleared
Dec 09, 2016
Slit Lamp SL-D301
HJO
Biomicroscope, Slit-lamp, Ac-powered
144d
Cleared
Dec 09, 2016
EnFocus 2300, EnFocus 4400
OBO
Tomography, Optical Coherence
67d
Cleared
Dec 09, 2016
Contact Lens Case
LRX
Case, Contact Lens
57d
Cleared
Dec 08, 2016
Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens
HQD
Lens, Contact (other Material) - Daily
141d
Cleared
Nov 30, 2016
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
LPL
Lenses, Soft Contact, Daily Wear
195d
Cleared
Nov 29, 2016
Lenstec LC Injection system
MSS
Folders And Injectors, Intraocular Lens (iol)
153d
Cleared
Nov 25, 2016
NNR06 Multi-Purpose Solution
LPN
Accessories, Soft Lens Products
147d
Cleared
Nov 21, 2016
XEN Glaucoma Treatment System
KYF
Implant, Eye Valve
179d
Cleared
Nov 18, 2016
LacriPro Punctum Plug
LZU
Plug, Punctum
155d
Cleared
Nov 16, 2016
LenSX Laser System
OOE
Ophthalmic Femtosecond Laser
191d
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