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
5106
Total
5088
Cleared
170d
Avg (2y)
1976
Since
1303 Ophthalmic devices
Cleared
Apr 07, 1998
KEELER TEARSCOPE-PLUS
HJO
Biomicroscope, Slit-lamp, Ac-powered
232d
Cleared
Mar 23, 1998
STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
42d
Cleared
Mar 11, 1998
SOFLENS(TM) ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
79d
Cleared
Mar 10, 1998
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
82d
Cleared
Mar 04, 1998
ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
LPN
Accessories, Soft Lens Products
83d
Cleared
Mar 04, 1998
OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER
LPN
Accessories, Soft Lens Products
83d
Cleared
Feb 24, 1998
MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL
HQC
Unit, Phacofragmentation
90d
Cleared
Jan 20, 1998
ALCON CONTACT LENS CASE
LRX
Case, Contact Lens
67d
Cleared
Jan 12, 1998
BAUSCH & LOMB2 SENSITIVE EYES MULTI-PURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
89d
Cleared
Dec 19, 1997
PREFERENCE 60 AND PREFERENCE 60 TORIC
LPL
Lenses, Soft Contact, Daily Wear
507d
Cleared
Dec 02, 1997
ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
LPN
Accessories, Soft Lens Products
89d
Cleared
Nov 04, 1997
NIDEK HANDY
HKI
Camera, Ophthalmic, Ac-powered
69d
Cleared
Nov 04, 1997
NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)
HKI
Camera, Ophthalmic, Ac-powered
47d
Cleared
Oct 10, 1997
STORZ MILLENNIUM VISCOUS FLUID SYSTEM
MRH
Pump, Infusion, Ophthalmic
86d
Cleared
Sep 30, 1997
DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR
HOZ
Sponge, Ophthalmic
74d
Cleared
Aug 08, 1997
OXYCOR (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
38d
Cleared
Jul 14, 1997
ALCON CONTACT LENS CASE
LRX
Case, Contact Lens
73d
Cleared
Jul 03, 1997
MS401097-17,MS722-K,MS720,MS721,MS722
HLJ
Ophthalmoscope, Battery-powered
352d
Cleared
Jun 30, 1997
WELCH ALLYN PHACO ILLUMINATOR
HQC
Unit, Phacofragmentation
49d
Cleared
Jun 17, 1997
STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES
HQC
Unit, Phacofragmentation
60d
Cleared
May 09, 1997
SEE3 (LOTRAFILCON A) SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
70d
Cleared
May 06, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS721-P
MSG
Ophthalmoscopes, Replacement Batteries, Hand-held
41d
Cleared
Apr 23, 1997
MONARCH IOL DELIVERY SYSTEM
KYB
Lens, Guide, Intraocular
110d
Cleared
Apr 02, 1997
KEELER SPECTRA INDIRECT OPHTHALMOSCOPE
HLJ
Ophthalmoscope, Battery-powered
89d
Cleared
Mar 31, 1997
ACRYPAK FOLDER
KYB
Lens, Guide, Intraocular
97d
Looking for a specific ophthalmic device? Search by device name, K-number or manufacturer.
Search all Ophthalmic 510(k) devices