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
2905 Ophthalmic devices
Cleared
Jul 12, 1983
LACIMAL INTUBATION SETS
HNL
Probe, Lachrymal
28d
Cleared
Jul 12, 1983
DISPOSABLE CYSTOTOME
HNY
Cystotome
28d
Cleared
Jul 12, 1983
MICRO SURGICAL HANDLE
KYG
Device, Irrigation, Ocular Surgery
21d
Cleared
Jun 30, 1983
SUN PHOTO-KERATOSCOPE
HLQ
Keratoscope, Ac-powered
87d
Cleared
Jun 30, 1983
INFUSION CANNULA
HMX
Cannula, Ophthalmic
79d
Cleared
Jun 30, 1983
SCLERAL PLUG
LXP
Plug, Scleral
79d
Cleared
Jun 30, 1983
EPSILON ULTRASONIC TIP
HQC
Unit, Phacofragmentation
23d
Cleared
Jun 10, 1983
AUTO REFRACTOMETER
HKO
Refractometer, Ophthalmic
67d
Cleared
Jun 08, 1983
ULTRAKIT
HQC
Unit, Phacofragmentation
58d
Cleared
Jun 02, 1983
CLERZ LUBRICATING & REWETTING EYE DROPS
HPX
Lens, Contact (polymethylmethacrylate)
86d
Cleared
May 16, 1983
LED GOGGLES
HLX
Photostimulator, Ac-powered
31d
Cleared
Apr 28, 1983
CONTRAST SENSITIVITY EQUIPMENT
HLX
Photostimulator, Ac-powered
48d
Cleared
Apr 28, 1983
OSCAR COLOR VISION TESTER
HIT
Tester, Color Vision
24d
Cleared
Apr 06, 1983
FLORET OPHTHALMIC EYE SPEAR
HOZ
Sponge, Ophthalmic
71d
Cleared
Apr 06, 1983
BINOCULAR MAGNIFIER 2X
HKC
Spectacle Microscope, Low-vision
26d
Cleared
Apr 06, 1983
BINOCULAR LOUPE
HJH
Loupe, Binocular, Low Power
19d
Cleared
Apr 05, 1983
IV STAND
HQC
Unit, Phacofragmentation
49d
Cleared
Mar 09, 1983
DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP
HLJ
Ophthalmoscope, Battery-powered
44d
Cleared
Mar 09, 1983
DORC COMPACT MICRO SURGICAL SYSTEM
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
44d
Cleared
Mar 09, 1983
DORC CONTACT/PHOTO DERATOSCOPE
HJA
Photokeratoscope
41d
Cleared
Mar 09, 1983
DORC CORNEAL PUNCH BLOCK
HNJ
Punch, Corneo-scleral
36d
Cleared
Mar 09, 1983
DORC INTRAOCULAR ELECTROMAGNET
HPO
Magnet, Ac-powered
36d
Cleared
Feb 24, 1983
AO DOCUSTAR(MMIRO) FUNDUS CAMERA
HKI
Camera, Ophthalmic, Ac-powered
135d
Cleared
Feb 07, 1983
DORC ADJUSTABLE IMAGE CONTACTS
HKS
Prism, Gonioscopic
20d
Cleared
Jan 21, 1983
HELIOSIT-ORTHODONTIC
DYH
Adhesive, Bracket And Tooth Conditioner, Resin
67d
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