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
Sep 09, 2013
BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION
LPN
Accessories, Soft Lens Products
54d
Cleared
Aug 30, 2013
EASY DAY (METHAFILCON A) 1-DAY SOFT (HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
148d
Cleared
Aug 30, 2013
SUS (STENFILCON A) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
108d
Cleared
Aug 30, 2013
SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A)
LPL
Lenses, Soft Contact, Daily Wear
50d
Cleared
Aug 06, 2013
MENICON NECT CONTACT LENS CASE
LRX
Case, Contact Lens
43d
Cleared
Aug 05, 2013
SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER
LPL
Lenses, Soft Contact, Daily Wear
175d
Cleared
Aug 02, 2013
SOLUTIS
HQF
Laser, Ophthalmic
120d
Cleared
Jul 29, 2013
OPHTACATH KIT
OKS
Lacrimal Stents And Intubation Sets
229d
Cleared
Jul 26, 2013
SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER
MVN
Lens, Contact, (disposable)
165d
Cleared
Jul 23, 2013
FORUM GLAUCOMA WORKPLACE
NFJ
System, Image Management, Ophthalmic
134d
Cleared
Jul 03, 2013
IFUSION
HKI
Camera, Ophthalmic, Ac-powered
113d
Cleared
Jul 03, 2013
MENICON UNIQUE PH MULTI-PURPOSE SOLUTION
MRC
Products, Contact Lens Care, Rigid Gas Permeable
100d
Cleared
Jul 01, 2013
ELLEX 2RT
HQF
Laser, Ophthalmic
341d
Cleared
Jun 27, 2013
KEELER SLIT LAMP H-SERIES
HJO
Biomicroscope, Slit-lamp, Ac-powered
27d
Cleared
Jun 26, 2013
23GA CURVED ILLUMINATING LASER PROBE
HQB
Photocoagulator And Accessories
272d
Cleared
Jun 17, 2013
DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D
LPL
Lenses, Soft Contact, Daily Wear
222d
Cleared
Jun 13, 2013
STANDARD CONTACT LENS CASE
LRX
Case, Contact Lens
86d
Cleared
Jun 05, 2013
TRC-50DX RETINAL CAMERA
HKI
Camera, Ophthalmic, Ac-powered
244d
Cleared
May 31, 2013
PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES
LRX
Case, Contact Lens
269d
Cleared
May 30, 2013
PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
230d
Cleared
May 16, 2013
CRYSTALSERT DELIVERY SYSTEM
MSS
Folders And Injectors, Intraocular Lens (iol)
162d
Cleared
May 15, 2013
PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER
HQF
Laser, Ophthalmic
177d
Cleared
May 15, 2013
SAUFLON MULTIPURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
58d
Cleared
May 13, 2013
LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE
LPL
Lenses, Soft Contact, Daily Wear
426d
Cleared
May 10, 2013
BOSTON KERATOPROSTHESIS OR BOSTON KPRO
HQM
Keratoprosthesis, Permanent Implant
385d
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