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 11, 2015
23ga Chandelier Illuminator, 25ga Chandelier Illuminator
MPA
Endoilluminator
88d
Cleared
Sep 10, 2015
Keeler Slit Lamp
HJO
Biomicroscope, Slit-lamp, Ac-powered
107d
Cleared
Sep 02, 2015
COMPACT INTUITIV Multiple-Use Pack
HQC
Unit, Phacofragmentation
63d
Cleared
Sep 01, 2015
CIRRUS HD-OCT
OBO
Tomography, Optical Coherence
141d
Cleared
Sep 01, 2015
Dynarex Eye Cups
LXQ
Cup, Eye
82d
Cleared
Aug 28, 2015
PDO Absorbable Punctum Plug
LZU
Plug, Punctum
204d
Cleared
Aug 28, 2015
Menicon Saline Rinse Solution
LPN
Accessories, Soft Lens Products
59d
Cleared
Aug 18, 2015
Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
33d
Cleared
Aug 17, 2015
Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants
MML
Weights, Eyelid, External
125d
Cleared
Aug 10, 2015
Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
60d
Cleared
Aug 06, 2015
Cornea Cold
LYX
Media, Corneal Storage
108d
Cleared
Jul 14, 2015
Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow
HQF
Laser, Ophthalmic
321d
Cleared
Jul 10, 2015
IOLMaster700
HJO
Biomicroscope, Slit-lamp, Ac-powered
238d
Cleared
Jul 10, 2015
CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear,
LPL
Lenses, Soft Contact, Daily Wear
123d
Cleared
Jun 30, 2015
COMPASS
MYC
Ophthalmoscope, Laser, Scanning
141d
Cleared
Jun 25, 2015
Ophthalmed Bending Laser Probes
HQF
Laser, Ophthalmic
268d
Cleared
Jun 24, 2015
VICTUS Femtosecond Laser Platform
OOE
Ophthalmic Femtosecond Laser
54d
Cleared
Jun 22, 2015
VISCO SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
396d
Not Cleared
Jun 18, 2015
BRAINPORT V100 DEVICE
PIC
Oral Electronic Vision Aid
680d
Cleared
Jun 15, 2015
Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear
MVN
Lens, Contact, (disposable)
96d
Cleared
Jun 01, 2015
VX120 Ophthalmic Diagnostic Device
HKX
Tonometer, Ac-powered
217d
Cleared
May 29, 2015
SP-1PSpecular Microscope
NQE
Microscope, Specular
274d
Cleared
May 22, 2015
Bausch + Lomb Injector System
MSS
Folders And Injectors, Intraocular Lens (iol)
28d
Cleared
May 21, 2015
Retina Workplace
NFJ
System, Image Management, Ophthalmic
87d
Cleared
May 18, 2015
HEINE BETA 200, HEINE BETA 200 S, HEINE K 180
HLJ
Ophthalmoscope, Battery-powered
256d
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