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
Aug 22, 2002
BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS
HQD
Lens, Contact (other Material) - Daily
52d
Cleared
Aug 12, 2002
MULTIVISION METHAFILCON A SOFT (HYDROPILIC) MULTIFOCAL LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
80d
Cleared
Aug 08, 2002
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
LPN
Accessories, Soft Lens Products
121d
Cleared
Aug 08, 2002
LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR
HQF
Laser, Ophthalmic
90d
Cleared
Aug 06, 2002
F 900
HKY
Tonometer, Manual
43d
Cleared
Aug 05, 2002
MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT
HPZ
Implant, Eye Sphere
98d
Cleared
Jul 26, 2002
SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG
LZU
Plug, Punctum
130d
Cleared
Jul 26, 2002
ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM
HKI
Camera, Ophthalmic, Ac-powered
23d
Cleared
Jul 09, 2002
HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030
HQC
Unit, Phacofragmentation
140d
Cleared
Jul 02, 2002
INFINITI
HQC
Unit, Phacofragmentation
50d
Cleared
Jul 01, 2002
OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB
LZU
Plug, Punctum
27d
Cleared
Jun 27, 2002
SOFT PLUG ABSORBABLE PLUG-SA
LZU
Plug, Punctum
234d
Cleared
Jun 21, 2002
VISUCAM
NFF
Device, Storage, Images, Ophthalmic
22d
Cleared
Jun 19, 2002
HANSATOME EXCELLUS MICROKERATOME
HNO
Keratome, Ac-powered
30d
Cleared
Jun 04, 2002
BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS
MVN
Lens, Contact, (disposable)
119d
Cleared
Jun 04, 2002
IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL 55 UV MULTIFOCAL (METHAFILCON A) SOFT
LPL
Lenses, Soft Contact, Daily Wear
81d
Cleared
Jun 04, 2002
SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
41d
Cleared
May 31, 2002
RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION
LYL
Accessories, Solution, Ultrasonic Cleaners For Lenses
80d
Cleared
May 30, 2002
ROSE K POST GRAFT LENS
HQD
Lens, Contact (other Material) - Daily
206d
Cleared
May 24, 2002
SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
86d
Cleared
May 16, 2002
HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)
LPL
Lenses, Soft Contact, Daily Wear
80d
Cleared
May 16, 2002
SURGE-FREE ASPIRATION ADAPTER
HQC
Unit, Phacofragmentation
71d
Cleared
May 16, 2002
BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
56d
Cleared
May 09, 2002
CHROMAGEN V3.0 READING AID SOFT CONTACT LENS
NIC
Lens, Contact, For Reading Discomfort
304d
Cleared
May 06, 2002
SAVIEW 55F (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
46d
Looking for a specific ophthalmic device? Search by device name, K-number or manufacturer.
Search all Ophthalmic 510(k) devices