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
Apr 05, 2005
VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1
HJO
Biomicroscope, Slit-lamp, Ac-powered
106d
Cleared
Apr 05, 2005
SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK
HQC
Unit, Phacofragmentation
22d
Cleared
Mar 28, 2005
FRESHLOOK ONE-DAY COLOR CONTACT LENS
MVN
Lens, Contact, (disposable)
56d
Cleared
Mar 28, 2005
VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
18d
Cleared
Mar 25, 2005
EPI-K
HNO
Keratome, Ac-powered
128d
Cleared
Mar 24, 2005
Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II
HQF
Laser, Ophthalmic
84d
Cleared
Feb 25, 2005
THERMAL CAUTERY PROBE
HQR
Apparatus, Cautery, Radiofrequency, Ac-powered
17d
Cleared
Feb 14, 2005
VISCUCAM C DIGITAL CAMERA
HKI
Camera, Ophthalmic, Ac-powered
84d
Cleared
Feb 07, 2005
FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA
HQF
Laser, Ophthalmic
77d
Cleared
Feb 01, 2005
HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES
LPL
Lenses, Soft Contact, Daily Wear
41d
Cleared
Jan 31, 2005
AMADEUS II EPIKERATOME
HNO
Keratome, Ac-powered
77d
Cleared
Jan 28, 2005
PACHYCAM
MXK
Device, Analysis, Anterior Segment
204d
Cleared
Jan 25, 2005
I-PROMOTIONS CONTACT LENS CASE
LRX
Case, Contact Lens
125d
Cleared
Jan 21, 2005
OCT-OPTHALMOSCOPE
HLI
Ophthalmoscope, Ac-powered
94d
Cleared
Jan 12, 2005
PROCLEAR ULTRAVUE MULTIFOCAL AND PROCLEAR ULTRAVUE 2000T MULTIFOCAL TORIC (OMAFLICON A) SOFT (HYDROPHILIC CONTACT LENS)
LPL
Lenses, Soft Contact, Daily Wear
61d
Cleared
Dec 28, 2004
CAPSULE TENSION RING INSERTER, MODEL 7-810
NCE
Injector, Capsular Tension Ring
106d
Cleared
Dec 10, 2004
TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH)
HKX
Tonometer, Ac-powered
128d
Cleared
Dec 09, 2004
STARION UNIVERSAL POWER SUPPLY (UPS)
HQO
Unit, Cautery, Thermal, Ac-powered
24d
Cleared
Nov 18, 2004
SELF RETAINING BICANALICULUS INTUBATION SET
OKS
Lacrimal Stents And Intubation Sets
132d
Cleared
Nov 16, 2004
MODIFICATION TO VISITOME 20-10 MICROKERATOME
HNO
Keratome, Ac-powered
105d
Cleared
Nov 16, 2004
FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
35d
Cleared
Nov 05, 2004
TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA
HKI
Camera, Ophthalmic, Ac-powered
165d
Cleared
Nov 03, 2004
AQUIFY LENS COMFORT DROPS
LPN
Accessories, Soft Lens Products
84d
Cleared
Oct 28, 2004
KARATS MULTIPURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
511d
Cleared
Oct 28, 2004
VISTAKON (SENOFILCON A) SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
66d
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