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
2888 Ophthalmic devices
Cleared
Aug 24, 2005
OPD-STATION SOFTWARE
NCF
Aberrometer, Ophthalmic
195d
Cleared
Aug 19, 2005
DELTA PUNCTUM PLUG
LZU
Plug, Punctum
137d
Cleared
Aug 18, 2005
MICROPULSE PHACOEMULSIFICATION SYSTEM
HQC
Unit, Phacofragmentation
101d
Cleared
Aug 16, 2005
55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
110d
Cleared
Aug 12, 2005
DISCON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
101d
Cleared
Aug 12, 2005
ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR
MVN
Lens, Contact, (disposable)
30d
Cleared
Aug 10, 2005
AQUIFY MULTIPURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
188d
Cleared
Jul 29, 2005
LENS PLUS REWETTING DROPS
LPN
Accessories, Soft Lens Products
311d
Cleared
Jul 18, 2005
EXTREME H2O 54% (HIOXIFILCON D) SOFT CONTACT LENS (SPHERICAL AND TORIC)
LPL
Lenses, Soft Contact, Daily Wear
47d
Cleared
Jul 06, 2005
NORWOOD ABBEY CENTURION SES EPIKERATOME
HNO
Keratome, Ac-powered
30d
Cleared
Jul 01, 2005
55 SV, MULTIFOCAL AND TORIC (OCUFILCON C) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
53d
Cleared
Jun 29, 2005
SUPER VIEW DISPOSABLE BIOM LENS SET
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
12d
Cleared
Jun 16, 2005
EYE CUP, STERILE 1 AND NON STERILE
LXQ
Cup, Eye
16d
Cleared
Jun 07, 2005
HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
39d
Cleared
May 31, 2005
LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES
MSS
Folders And Injectors, Intraocular Lens (iol)
81d
Cleared
May 31, 2005
LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
56d
Cleared
May 27, 2005
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES
MVN
Lens, Contact, (disposable)
135d
Cleared
May 18, 2005
PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
33d
Cleared
May 13, 2005
PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T MULTIFOCAL TORIC
LPL
Lenses, Soft Contact, Daily Wear
53d
Cleared
May 09, 2005
OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY
HQF
Laser, Ophthalmic
68d
Cleared
Apr 29, 2005
THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP)
HPT
Perimeter, Automatic, Ac-powered
77d
Cleared
Apr 26, 2005
MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
91d
Cleared
Apr 21, 2005
ISCIENCE SURGICAL VISCOINJECTOR
MRH
Pump, Infusion, Ophthalmic
31d
Cleared
Apr 13, 2005
JSZ-MULTIPURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
43d
Cleared
Apr 13, 2005
AQUAFLEX 2 (TEFILCON) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
23d
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