FDA Review Panel · OP

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
301–325 of 2876
Cleared Sep 25, 2020
ImageSPECTRUM
K201273 · Canon, Inc.
NFJ · System, Image Management, Ophthalmic · 136d
Not Cleared Sep 24, 2020
Tangible Boost
DEN200002 · Tangible Science, Inc.
QMM · Hydrophilic Re-coating Solution · 255d
Cleared Sep 23, 2020
Boston One Step Liquid Enzymatic Cleaner
K200416 · Bausch & Lomb, Incorporated
MRC · Products, Contact Lens Care, Rigid Gas Permeable · 216d
Cleared Sep 22, 2020
DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
K202448 · Alcon Laboratories, Inc.
MVN · Lens, Contact, (disposable) · 27d
Cleared Sep 18, 2020
Optixon 1-Day
K201013 · Optixon, Inc.
LPL · Lenses, Soft Contact, Daily Wear · 154d
Cleared Sep 10, 2020
RxSight Contact Lens
K201909 · Rxsight, Inc.
HJK · Lens, Contact, Polymethylmethacrylate, Diagnostic · 63d
Cleared Sep 09, 2020
Spectralis HRA+OCT and variants
K201252 · Heidelberg Engineering GmbH
OBO · Tomography, Optical Coherence · 121d
Cleared Sep 08, 2020
Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
K201194 · Acuity Polymers, Inc.
HQD · Lens, Contact (other Material) - Daily · 127d
Cleared Sep 02, 2020
OCT-Camera ID 21101A3
K200516 · Optomedical Technologies GmbH
OBO · Tomography, Optical Coherence · 184d
Cleared Sep 01, 2020
VICTUS Femtosecond Laser Platform
K200724 · Technolas Perfect Vision GmbH
OOE · Ophthalmic Femtosecond Laser · 166d
Cleared Aug 31, 2020
TrueTear Intranasal Tear Neurostimulator
K193589 · Allergan
QBR · Intranasal Electrostimulation Device For Dry Eye Symptoms · 252d
Cleared Aug 21, 2020
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
K202036 · Alcon Laboratories, Inc.
MVN · Lens, Contact, (disposable) · 29d
Cleared Aug 11, 2020
LION Photocoagulator
K201623 · Norlase Aps
HQF · Laser, Ophthalmic · 57d
Cleared Aug 11, 2020
OMNI PLUS Surgical System
K201953 · Sight Sciences, Inc.
MRH · Pump, Infusion, Ophthalmic · 28d
Cleared Aug 06, 2020
Vitra 810
K201502 · Quantel Medical
HQF · Laser, Ophthalmic · 62d
Cleared Aug 03, 2020
EyeArt
K200667 · Eyenuk, Inc.
PIB · Diabetic Retinopathy Detection Device · 143d
Cleared Aug 03, 2020
Glaucoma Module
K200954 · Topcon Healthcare Solutions, Inc.
NFJ · System, Image Management, Ophthalmic · 116d
Cleared Jul 31, 2020
xPORT 304 (miCOR) System Lens Fragmentation System
K200584 · Carl Zeiss Meditec Cataract Technology, Inc.
HQC · Unit, Phacofragmentation · 147d
Cleared Jul 31, 2020
VibrantVue Scleral Saline
K201069 · Dry Eye Innovations, LLC
MRC · Products, Contact Lens Care, Rigid Gas Permeable · 100d
Cleared Jul 23, 2020
Canon non-mydriatic retinal camera CR series
K201122 · Canon, Inc.
HKI · Camera, Ophthalmic, Ac-powered · 87d
Cleared Jul 15, 2020
Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens
K201080 · Visco Vision, Inc.
LPL · Lenses, Soft Contact, Daily Wear · 84d
Cleared Jul 14, 2020
Orbit Subretinal Delivery System
K200325 · Orbit Biomedical
FMF · Syringe, Piston · 155d
Cleared Jun 17, 2020
Miru 1day UpSide (midafilcon A)
K193399 · Menicon Co, Ltd.
LPL · Lenses, Soft Contact, Daily Wear · 194d
Cleared Jun 15, 2020
Visalis V500, Visalis S500
K193376 · Carl Zeiss Meditec, AG
HQC · Unit, Phacofragmentation · 193d
Cleared Jun 04, 2020
bioli lOL Delivery System
K200057 · Ast Products, Inc.
MSS · Folders And Injectors, Intraocular Lens (iol) · 143d

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All categories 2876 LPL Lenses, Soft Contact, Daily Wear 359 HQC Unit, Phacofragmentation 196 HQF Laser, Ophthalmic 140 HQY Sunglasses (non-prescription Including Photosensitive) 124 HKI Camera, Ophthalmic, Ac-powered 110 HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered 93 LPN Accessories, Soft Lens Products 91 HQD Lens, Contact (other Material) - Daily 89 HJO Biomicroscope, Slit-lamp, Ac-powered 73 HLI Ophthalmoscope, Ac-powered 71 OBO Tomography, Optical Coherence 61 HNO Keratome, Ac-powered 59 HMX Cannula, Ophthalmic 49 NFJ System, Image Management, Ophthalmic 49 MSS Folders And Injectors, Intraocular Lens (iol) 49