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
5100
Total
5082
Cleared
170d
Avg (2y)
1976
Since
490 Ophthalmic devices
Cleared
Jul 31, 2023
QUATERA 700
HQC
Unit, Phacofragmentation
124d
Cleared
Jul 31, 2023
Altris IMS
NFJ
System, Image Management, Ophthalmic
18d
Cleared
Jun 29, 2023
MYAH
MXK
Device, Analysis, Anterior Segment
276d
Cleared
Jun 16, 2023
EyeArt v2.2.0
PIB
Diabetic Retinopathy Detection Device
226d
Cleared
Jun 16, 2023
NewVision SC (tisilfocon A) Scleral Lens
HQD
Lens, Contact (other Material) - Daily
77d
Cleared
Jun 16, 2023
Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens
HQD
Lens, Contact (other Material) - Daily
72d
Cleared
Jun 12, 2023
RxSight Insertion Device
MSS
Folders And Injectors, Intraocular Lens (iol)
24d
Cleared
Jun 02, 2023
CorNeat EverPatch
QWU
Prosthesis, Eyelid Spacer/graft, Polymer
245d
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 FP7
KYF
Implant, Eye Valve
37d
Cleared
May 12, 2023
Ahmed® Glaucoma Valve Model FP8
KYF
Implant, Eye Valve
29d
Cleared
May 09, 2023
Retitrack
HLL
Monitor, Eye Movement
265d
Cleared
May 05, 2023
Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses
HQD
Lens, Contact (other Material) - Daily
322d
Cleared
Apr 20, 2023
Precision1, Precision1 for Astigmatism
LPL
Lenses, Soft Contact, Daily Wear
29d
Cleared
Apr 14, 2023
ELITA™ Femtosecond Laser System, ELITA™ Patient Interface
OOE
Ophthalmic Femtosecond Laser
136d
Cleared
Apr 13, 2023
CIRRUS HD-OCT
OBO
Tomography, Optical Coherence
262d
Cleared
Apr 12, 2023
Catalys™ Precision Laser System
OOE
Ophthalmic Femtosecond Laser
111d
Cleared
Apr 11, 2023
ZeptoLink IOL Positioning System
PUL
Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-powered
117d
Cleared
Mar 30, 2023
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX
OBO
Tomography, Optical Coherence
328d
Cleared
Mar 30, 2023
ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System
MPA
Endoilluminator
275d
Cleared
Mar 15, 2023
iExaminer System with Panoptic Plus
HKI
Camera, Ophthalmic, Ac-powered
128d
Cleared
Mar 13, 2023
Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
167d
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
Feb 23, 2023
Iridex 532 Laser
HQF
Laser, Ophthalmic
27d
Cleared
Feb 22, 2023
Eyer Retinal Camera NM-STD
HKI
Camera, Ophthalmic, Ac-powered
292d
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