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
Jan 30, 2004
PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD
HNO
Keratome, Ac-powered
121d
Cleared
Jan 20, 2004
NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER
HKX
Tonometer, Ac-powered
133d
Cleared
Jan 13, 2004
SURGICAL MEDICAL DEVICE CAUTERY
HQP
Unit, Cautery, Thermal, Battery-powered
452d
Cleared
Jan 13, 2004
MED-LOGICS, MODEL ML7090
HNO
Keratome, Ac-powered
91d
Cleared
Dec 19, 2003
TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
HKO
Refractometer, Ophthalmic
189d
Cleared
Dec 17, 2003
VENTURI PHACO PACK
HQC
Unit, Phacofragmentation
26d
Cleared
Dec 15, 2003
EUSOL-C
LYX
Media, Corneal Storage
132d
Cleared
Dec 15, 2003
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES
MVN
Lens, Contact, (disposable)
20d
Cleared
Dec 12, 2003
AMNIOLENS
NQB
Conformer, Ophthalmic, Biological Tissue
157d
Cleared
Dec 04, 2003
NON-CONTACT TONOMETER, MODEL NT-4000
HKX
Tonometer, Ac-powered
183d
Cleared
Dec 04, 2003
NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY
LRX
Case, Contact Lens
132d
Cleared
Dec 04, 2003
VISION-TECH YZ SLIT LAMP, MODEL 66
HJO
Biomicroscope, Slit-lamp, Ac-powered
64d
Cleared
Nov 26, 2003
KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004
HLJ
Ophthalmoscope, Battery-powered
142d
Cleared
Nov 24, 2003
SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
MPA
Endoilluminator
91d
Cleared
Nov 14, 2003
BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03
LPN
Accessories, Soft Lens Products
170d
Cleared
Nov 14, 2003
PASCAL DYNAMIC CONTOUR TONOMETER
HKY
Tonometer, Manual
52d
Cleared
Nov 07, 2003
PROCLEAR COMPATIBLES MULTIFOCAL
LPL
Lenses, Soft Contact, Daily Wear
53d
Cleared
Nov 04, 2003
THERATEARS CONTACT LENS COMFORT DROPS
LPN
Accessories, Soft Lens Products
84d
Cleared
Nov 04, 2003
COLIBRI DISPOSABLE VITRECTOMY CUTTER
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
12d
Cleared
Oct 20, 2003
MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME
HNO
Keratome, Ac-powered
26d
Cleared
Oct 16, 2003
VISTAKON (GALYFILCON A) SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
79d
Cleared
Oct 10, 2003
CLUED UP MULTIPURPOSE SOLUTION- NO RUB
LPN
Accessories, Soft Lens Products
200d
Cleared
Oct 06, 2003
DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM
MSS
Folders And Injectors, Intraocular Lens (iol)
300d
Cleared
Sep 25, 2003
OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER
MXK
Device, Analysis, Anterior Segment
232d
Cleared
Sep 25, 2003
BLINK CL LUBRICANT EYE DROPS
LPN
Accessories, Soft Lens Products
86d
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