FDA 510(k) Ophthalmic Devices
About Ophthalmic Devices
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
5094
Total
5076
Cleared
109d
Avg days
1976
Since
148 Ophthalmic devices
Cleared
Jul 31, 2023
QUATERA 700
HQC
Unit, Phacofragmentation
124d
Cleared
May 31, 2023
Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
LPL
Lenses, Soft Contact, Daily Wear
250d
Cleared
May 12, 2023
Ahmed® Glaucoma Valve Model FP8
KYF
Implant, Eye Valve
29d
Cleared
May 12, 2023
Ahmed® Glaucoma Valve Model FP7
KYF
Implant, Eye Valve
37d
Cleared
Apr 20, 2023
Precision1, Precision1 for Astigmatism
LPL
Lenses, Soft Contact, Daily Wear
29d
Cleared
Apr 13, 2023
CIRRUS HD-OCT
OBO
Tomography, Optical Coherence
262d
Cleared
Mar 30, 2023
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX
OBO
Tomography, Optical Coherence
328d
Cleared
Mar 15, 2023
iExaminer System with Panoptic Plus
HKI
Camera, Ophthalmic, Ac-powered
128d
Cleared
Mar 08, 2023
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
LPL
Lenses, Soft Contact, Daily Wear
370d
Cleared
Dec 06, 2022
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
LPN
Accessories, Soft Lens Products
106d
Cleared
Sep 15, 2022
AIR OPTIX COLORS
LPL
Lenses, Soft Contact, Daily Wear
28d
Cleared
Aug 15, 2022
FORUM
NFJ
System, Image Management, Ophthalmic
284d
Cleared
May 12, 2022
Capsulo
HQF
Laser, Ophthalmic
86d
Cleared
Apr 19, 2022
QUATERA 700
HQC
Unit, Phacofragmentation
274d
Cleared
Feb 04, 2022
MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
25d
Cleared
Dec 28, 2021
Alcon (serafilcon A) soft contact lenses for daily wear
LPL
Lenses, Soft Contact, Daily Wear
116d
Cleared
Dec 03, 2021
Independent Corneal Viewing Chamber (IVC-21)
LYX
Media, Corneal Storage
177d
Cleared
Oct 26, 2021
Avaira Vitality
LPL
Lenses, Soft Contact, Daily Wear
28d
Cleared
Aug 23, 2021
CLAREON MONARCH IV IOL Delivery System
MSS
Folders And Injectors, Intraocular Lens (iol)
54d
Cleared
May 28, 2021
ABT12 multi-purpose solution
LPN
Accessories, Soft Lens Products
241d
Cleared
May 24, 2021
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
LPL
Lenses, Soft Contact, Daily Wear
53d
Cleared
Apr 12, 2021
Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere
LPL
Lenses, Soft Contact, Daily Wear
59d
Not Cleared
Feb 23, 2021
Lumenis Stellar M22
QIU
Intense Pulsed Light Device For Managing Dry Eye
309d
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