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 20, 1998
KERATOME SYSTEM
HMY
Keratome, Battery-powered
69d
Cleared
Jan 20, 1998
ALCON CONTACT LENS CASE
LRX
Case, Contact Lens
67d
Cleared
Jan 20, 1998
PHACOPAK
HQC
Unit, Phacofragmentation
33d
Cleared
Jan 16, 1998
ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET
OKS
Lacrimal Stents And Intubation Sets
183d
Cleared
Jan 12, 1998
BAUSCH & LOMB2 SENSITIVE EYES MULTI-PURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
89d
Cleared
Jan 12, 1998
SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
42d
Cleared
Jan 09, 1998
SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
45d
Cleared
Jan 08, 1998
ATRION MEDICAL COATED LACRIMAL INTUBATION SET
OKS
Lacrimal Stents And Intubation Sets
90d
Cleared
Jan 08, 1998
AUTOMATED DISPOSABLE KERATOME (ADK)
HNO
Keratome, Ac-powered
79d
Cleared
Dec 19, 1997
PREFERENCE 60 AND PREFERENCE 60 TORIC
LPL
Lenses, Soft Contact, Daily Wear
507d
Cleared
Dec 17, 1997
MPORT FOLDABLE LENS PLACEMENT SYSTEM
MSS
Folders And Injectors, Intraocular Lens (iol)
292d
Cleared
Dec 17, 1997
BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)
MML
Weights, Eyelid, External
259d
Cleared
Dec 17, 1997
ULTRACELL SUCTION SPONGE
HOZ
Sponge, Ophthalmic
156d
Cleared
Dec 16, 1997
OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP
MTZ
Wrap, Implant, Orbital
88d
Cleared
Dec 12, 1997
RETINAL CUBE
HKI
Camera, Ophthalmic, Ac-powered
57d
Cleared
Dec 08, 1997
SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
82d
Cleared
Dec 08, 1997
FRAG COMMANDER
HQC
Unit, Phacofragmentation
68d
Cleared
Dec 08, 1997
AL-47 TORIC (ISOFILCON) SOFT (TORIC) DAILY WEAR CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
61d
Cleared
Dec 08, 1997
AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK)
LPL
Lenses, Soft Contact, Daily Wear
52d
Cleared
Dec 08, 1997
MULTI
HQY
Sunglasses (non-prescription Including Photosensitive)
14d
Cleared
Dec 02, 1997
ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
LPN
Accessories, Soft Lens Products
89d
Cleared
Dec 01, 1997
NON-PRESCRIPTION SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
25d
Cleared
Nov 25, 1997
WHITTINGHAM ULTRACLEAN PHACO HANDPIECE
HQC
Unit, Phacofragmentation
175d
Cleared
Nov 25, 1997
D.O.R.C. HEXON ILLUMINATION SYSTEM
MPA
Endoilluminator
90d
Cleared
Nov 24, 1997
BOSTON LIQUID ENZYMATIC CLEANER
LPN
Accessories, Soft Lens Products
89d
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