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
Dec 10, 1999
VIT ENHANCER
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
101d
Cleared
Nov 24, 1999
OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
141d
Cleared
Nov 24, 1999
METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV (TO BE MARKETED YR. 2000), FREQUENCY 55 ASP
MVN
Lens, Contact, (disposable)
57d
Cleared
Nov 19, 1999
I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
294d
Cleared
Nov 18, 1999
COLORMAX COLOR VISION ENHANCEMENT LENSES
NAI
Lens, Prescription, Color Deficiency
358d
Cleared
Nov 18, 1999
CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS
LPL
Lenses, Soft Contact, Daily Wear
78d
Cleared
Nov 16, 1999
RICROKERATOME BLADE
HNO
Keratome, Ac-powered
74d
Cleared
Nov 09, 1999
SL990, SL980, SL950
HJO
Biomicroscope, Slit-lamp, Ac-powered
78d
Cleared
Nov 02, 1999
LM-70 (LIDOFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT)
LPL
Lenses, Soft Contact, Daily Wear
221d
Cleared
Nov 02, 1999
KSEA DE LA PLAZA BLEPHAROPLASTY SET
HNI
Retractor, Ophthalmic
179d
Cleared
Oct 18, 1999
EXTREME H20 (HIOXIFILICON A) SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
68d
Cleared
Oct 07, 1999
REFRESH CONTACTS LUBRICATING AND REWETTING DROPS
LPN
Accessories, Soft Lens Products
113d
Cleared
Oct 04, 1999
OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
73d
Cleared
Oct 01, 1999
PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES
LYL
Accessories, Solution, Ultrasonic Cleaners For Lenses
113d
Cleared
Sep 24, 1999
MICROKERATOME, MODEL MK-2000
HNO
Keratome, Ac-powered
190d
Cleared
Sep 24, 1999
VISINE FOR CONTACTS
LPN
Accessories, Soft Lens Products
136d
Cleared
Sep 24, 1999
MILLENIUM MICROKERATOME, MODEL IMD-001
HMY
Keratome, Battery-powered
45d
Cleared
Sep 16, 1999
OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP
LPN
Accessories, Soft Lens Products
267d
Cleared
Sep 14, 1999
SAUFLON AEROTAB DISINFECTING SYSTEM FOR THE DISINFECTION OF SOFT (HYDROPHILIC) CONTACT LENSES
LPN
Accessories, Soft Lens Products
165d
Cleared
Aug 27, 1999
SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS
MZD
System, In-office Tinting, Contact Lenses
74d
Cleared
Aug 26, 1999
RESOLUTION 5X (SPHERICAL) AND ULTRA GEL 5X (TORIC)(HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS, (CLEAR & BLUE VISIBILITY
LPL
Lenses, Soft Contact, Daily Wear
24d
Cleared
Aug 18, 1999
DAILIES (NELFILCON A) ONE-DAY
MVN
Lens, Contact, (disposable)
27d
Cleared
Aug 18, 1999
CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
23d
Cleared
Aug 16, 1999
COLORSOFT PROSTHETIC TINTED SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
34d
Cleared
Aug 06, 1999
ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM
MXK
Device, Analysis, Anterior Segment
113d
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