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 21, 1987
RULE, PUPILLARY
HMM
Distometer
25d
Cleared
Sep 17, 1987
RESTORE
LPN
Accessories, Soft Lens Products
104d
Cleared
Sep 04, 1987
LASER CENTERING DEVICE
HMR
Marker, Ocular
53d
Cleared
Sep 04, 1987
TROKEL SINGLE MIRROR YAG LASER LENS
LQJ
Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
51d
Cleared
Sep 04, 1987
18MM PEYMAN WIDE FIELD YAG LASER LENS
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
49d
Cleared
Sep 04, 1987
MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
HNF
Scissors, Ophthalmic
28d
Cleared
Sep 04, 1987
VAN DELLEN RETROBULBAR NEEDLE
HMX
Cannula, Ophthalmic
24d
Cleared
Sep 04, 1987
VAN DELLEN IRRIGATING CYSTOTOME
HNY
Cystotome
24d
Cleared
Sep 04, 1987
VAN DELLEN HEALON CANNULA
HMX
Cannula, Ophthalmic
24d
Cleared
Aug 10, 1987
PART #860065 IA PAK & PART #860060 IA PAK
HQC
Unit, Phacofragmentation
118d
Cleared
Aug 10, 1987
PART #860070 ULTRAPAK & #860075 ULTRAPAK
HOC
Clip, Iris Retractor
118d
Cleared
Aug 10, 1987
SOFT CONTACT LENS REMOVER
KYE
Inserter/remover Contact Lens
42d
Cleared
Aug 10, 1987
SOLOS EYESITE CAP SLEEVE
HQC
Unit, Phacofragmentation
35d
Cleared
Aug 10, 1987
LOOK IRRIGATING/ASPIRATING CANNULA W/TEFLON SHEATH
HMX
Cannula, Ophthalmic
19d
Cleared
Aug 04, 1987
HARD CONTACT LENS REMOVER. ITEM #289
KYE
Inserter/remover Contact Lens
34d
Cleared
Jul 31, 1987
SOLOS EYESITE CANNULAS
HMX
Cannula, Ophthalmic
25d
Cleared
Jul 31, 1987
SOLOS EYESITE SPONGES
HOZ
Sponge, Ophthalmic
25d
Cleared
Jul 27, 1987
IN-LINE OPHTHALMIC IRRIGATING SOLUTION FILTERS
HQC
Unit, Phacofragmentation
75d
Cleared
Jul 27, 1987
FRIGITRONICS ACC-1000 CAPSULE CUTTER
HQC
Unit, Phacofragmentation
39d
Cleared
Jul 27, 1987
FH LEN
HQY
Sunglasses (non-prescription Including Photosensitive)
33d
Cleared
Jul 27, 1987
MELANITE I
HQG
Lens, Spectacle, Non-custom (prescription)
33d
Cleared
Jul 27, 1987
TAPELESS EYE SHIELD
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
20d
Cleared
Jul 22, 1987
EASY EYES TM LENS CARRYING CASE
LRX
Case, Contact Lens
78d
Cleared
Jul 21, 1987
EYE GARD
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
56d
Cleared
Jul 15, 1987
MODEL 3000 OPHTHALMIC SURGICAL SYSTEM
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
92d
Looking for a specific ophthalmic device? Search by device name, K-number or manufacturer.
Search all Ophthalmic 510(k) devices