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
May 18, 1987
TOPCON COMPUTERIZED TONOMETER CT-10
HKX
Tonometer, Ac-powered
45d
Cleared
May 18, 1987
ALLERGAN HUMPHREY AUTO-REFRACTOR, MODELS 525 & 540
HKO
Refractometer, Ophthalmic
38d
Cleared
May 18, 1987
TANNE CORNEAL CUTTING BLOCK
HNJ
Punch, Corneo-scleral
20d
Cleared
May 12, 1987
CONTACT LENS TWEEZERS
KYE
Inserter/remover Contact Lens
53d
Cleared
May 07, 1987
LASER CONTACT LENSES CGA 1, CGI 1, CGP 1, CGV 1
LQJ
Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
41d
Cleared
May 07, 1987
SITE PERISTALTIC MODULE SYSTEM
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
30d
Cleared
May 07, 1987
KRATZ NOVA-SERT
KYB
Lens, Guide, Intraocular
24d
Cleared
Apr 27, 1987
SCHIRMER NYLON SUTURE LASER LENS
LQJ
Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
39d
Cleared
Apr 27, 1987
KNIFE, OPHTHALMIC
HNN
Knife, Ophthalmic
27d
Cleared
Apr 27, 1987
DROP MATE
24d
Cleared
Apr 24, 1987
SURE DROP
50d
Cleared
Apr 22, 1987
SPECTACLE FRAMES VARIOUS COLORS AND DESIGNS
HQZ
Frame, Spectacle
97d
Cleared
Apr 16, 1987
SUNGLASSES AND SUNGLASS FRAMES VARIOUS COLORS
HQY
Sunglasses (non-prescription Including Photosensitive)
91d
Cleared
Apr 16, 1987
LEM SUNGLASSES & FRAMES DIFF. COLORS AND DESIGNS
HQY
Sunglasses (non-prescription Including Photosensitive)
85d
Cleared
Apr 16, 1987
LEM SPECTACLE FRAMES DIFFERENT COLORS AND DESIGNS
HQZ
Frame, Spectacle
85d
Cleared
Apr 16, 1987
CAPSULECTOMER CYSTOTOME
HNY
Cystotome
9d
Cleared
Apr 06, 1987
CONTAC CASE
LPN
Accessories, Soft Lens Products
187d
Cleared
Apr 06, 1987
MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUM
LYX
Media, Corneal Storage
75d
Cleared
Apr 06, 1987
MODIFIED MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUM
LYX
Media, Corneal Storage
75d
Cleared
Apr 06, 1987
CHONDROITIN SULFATE CORNEAL STORAGE MEDIUM
LYX
Media, Corneal Storage
75d
Cleared
Apr 06, 1987
PHACOTRON DAY PAK
HQC
Unit, Phacofragmentation
46d
Cleared
Mar 26, 1987
ENTRAVISION MODECO II VITREOUS CUTTING HANDPIECE
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
28d
Cleared
Mar 26, 1987
NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100
HQC
Unit, Phacofragmentation
28d
Cleared
Mar 20, 1987
LOOK RETROBULBAR NEEDLES
HMX
Cannula, Ophthalmic
15d
Cleared
Mar 17, 1987
KEELER PULSAIR NON CONTACT TONOMETER
HKX
Tonometer, Ac-powered
20d
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