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
Aug 02, 2022
iStent infinite Trabecular Micro-Bypass System, Model iS3
KYF
Implant, Eye Valve
209d
Cleared
Jul 15, 2022
Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems
HQF
Laser, Ophthalmic
112d
Cleared
Jun 24, 2022
EZYPOR
HPZ
Implant, Eye Sphere
298d
Cleared
Jun 23, 2022
ZEPTO Precision Capsulotomy System
PUL
Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-powered
59d
Cleared
Jun 17, 2022
IDx-DR v2.3
PIB
Diabetic Retinopathy Detection Device
269d
Cleared
Jun 14, 2022
EVA NEXUS Ophthalmic Surgical System
HQC
Unit, Phacofragmentation
229d
Cleared
Jun 09, 2022
ALLY Adaptive Cataract Treatment System
OOE
Ophthalmic Femtosecond Laser
129d
Cleared
Jun 08, 2022
TrabEx Pro
MRH
Pump, Infusion, Ophthalmic
253d
Cleared
Jun 03, 2022
SOFT PLUG Extended Duration 180 Tapered Canalicular Plug
LZU
Plug, Punctum
165d
Cleared
May 17, 2022
CATALYS Precision Laser system
OOE
Ophthalmic Femtosecond Laser
83d
Cleared
May 13, 2022
Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
228d
Cleared
May 12, 2022
Capsulo
HQF
Laser, Ophthalmic
86d
Cleared
May 04, 2022
Vista Ophthalmics Vitrectomy Probe
MLZ
Vitrectomy, Instrument Cutter
119d
Not Cleared
May 02, 2022
Kerasave
QCW
Corneal Storage Media With Preservatives Including Anti-fungal
578d
Cleared
Apr 28, 2022
RetinAI Discovery
NFJ
System, Image Management, Ophthalmic
329d
Cleared
Apr 27, 2022
Tomey Cornea/Anterior Segment OCT CASIA2
OBO
Tomography, Optical Coherence
209d
Cleared
Apr 21, 2022
FEMTO LDV Z8 Femtosecond Surgical Laser
OOE
Ophthalmic Femtosecond Laser
168d
Cleared
Apr 19, 2022
QUATERA 700
HQC
Unit, Phacofragmentation
274d
Cleared
Mar 23, 2022
Iridex 810 Laser
HQF
Laser, Ophthalmic
131d
Cleared
Mar 17, 2022
Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses
HQD
Lens, Contact (other Material) - Daily
210d
Cleared
Mar 16, 2022
iTEAR100 Neurostimulator
QKV
Electromechanical Tear Stimulator
120d
Cleared
Mar 01, 2022
MYAH
MXK
Device, Analysis, Anterior Segment
258d
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
Feb 02, 2022
EndoSerter-PL
OTZ
Graft Insertion Instrument For Endothelial Keratoplasty
421d
Cleared
Feb 02, 2022
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses
LPL
Lenses, Soft Contact, Daily Wear
254d
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