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
5110
Total
5092
Cleared
168d
Avg (2y)
1976
Since
2876 Ophthalmic devices
Cleared
Sep 19, 2023
Accuject Refra Injector AR2900
MSS
Folders And Injectors, Intraocular Lens (iol)
153d
Cleared
Sep 12, 2023
Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse
HQF
Laser, Ophthalmic
155d
Cleared
Sep 06, 2023
Phoenix ICON, Phoenix ICON GO
HKI
Camera, Ophthalmic, Ac-powered
280d
Cleared
Sep 06, 2023
IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
LPL
Lenses, Soft Contact, Daily Wear
166d
Cleared
Sep 01, 2023
MS-39
OBO
Tomography, Optical Coherence
456d
Cleared
Aug 30, 2023
Phoenix Contact Lens Case - dome top flat pack (CL-01)
LRX
Case, Contact Lens
132d
Cleared
Aug 28, 2023
CALLISTO eye
NFJ
System, Image Management, Ophthalmic
80d
Cleared
Aug 25, 2023
OMNI Surgical System
MRH
Pump, Infusion, Ophthalmic
30d
Cleared
Aug 18, 2023
P200TE (A10700)
OBO
Tomography, Optical Coherence
71d
Cleared
Aug 15, 2023
RxSight® Insertion Device (63002)
MSS
Folders And Injectors, Intraocular Lens (iol)
54d
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
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