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
2883 Ophthalmic devices
626–650 of 2883
Cleared Jan 20, 2016
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal
K153642 · Alcon Laboratories, Inc.
LPL · Lenses, Soft Contact, Daily Wear · 30d
Cleared Jan 20, 2016
Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
K153643 · Alcon Laboratories, Inc.
LPL · Lenses, Soft Contact, Daily Wear · 30d
Cleared Jan 15, 2016
Falck Medical Multifunction Tonometer, FAT1
K151491 · Falck Medical, Inc.
HKY · Tonometer, Manual · 226d
Cleared Jan 14, 2016
LipiView II Ocular Surface Interferometer
K152869 · Tearscience, Inc.
HKI · Camera, Ophthalmic, Ac-powered · 106d
Cleared Dec 31, 2015
KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100
K152644 · Keeler Limited
HKY · Tonometer, Manual · 106d
Cleared Dec 24, 2015
BrainPort V100
K152851 · Wicab, Inc.
PIC · Oral Electronic Vision Aid · 86d
Cleared Dec 17, 2015
Molteno3 Glaucoma Implant
K152996 · Innovative Ophthalmic Products, Inc. (Iop)
KYF · Implant, Eye Valve · 65d
Cleared Dec 02, 2015
EnFocus 2300, EnFocus 4400
K150722 · Bioptigen, Inc.
HLI · Ophthalmoscope, Ac-powered · 257d
Cleared Nov 24, 2015
Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)
K152046 · Art Optical Contact Lens, Inc.
LPL · Lenses, Soft Contact, Daily Wear · 124d
Cleared Oct 30, 2015
MicroSTAAR Injector System Cartridges
K152357 · STAAR Surgical Company
KYB · Lens, Guide, Intraocular · 71d
Cleared Oct 23, 2015
FEMTO LDV Z8 Surgical Laser
K150323 · Sie Ag,Surgical Instrument Engineering
OOE · Ophthalmic Femtosecond Laser · 256d
Cleared Oct 19, 2015
AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control
K151636 · Abbott Medical Optics, Inc.
HQC · Unit, Phacofragmentation · 124d
Cleared Oct 15, 2015
LENSAR Laser System - fs 3D (LLS-fs 3D)
K152453 · Lensar, Inc.
OOE · Ophthalmic Femtosecond Laser · 48d
Cleared Oct 13, 2015
Sensor Medical Single Use Tonometer Prism
K152308 · Sensor Medical Technology, LLC
HKY · Tonometer, Manual · 60d
Cleared Oct 02, 2015
ARGOS
K150754 · Santec Corporation
MXK · Device, Analysis, Anterior Segment · 193d
Cleared Oct 01, 2015
Synergy ODM
K151952 · Topcon Medical Systems, Inc.
NFJ · System, Image Management, Ophthalmic · 78d
Cleared Sep 11, 2015
23ga Chandelier Illuminator, 25ga Chandelier Illuminator
K151604 · Peregrine Surgical , Ltd.
MPA · Endoilluminator · 88d
Cleared Sep 10, 2015
Keeler Slit Lamp
K151394 · Keeler Limited
HJO · Biomicroscope, Slit-lamp, Ac-powered · 107d
Cleared Sep 02, 2015
COMPACT INTUITIV Multiple-Use Pack
K151783 · Abbott Medical Optics, Inc.
HQC · Unit, Phacofragmentation · 63d
Cleared Sep 01, 2015
CIRRUS HD-OCT
K150977 · Carl Zeiss Meditec, Inc.
OBO · Tomography, Optical Coherence · 141d
Cleared Sep 01, 2015
Dynarex Eye Cups
K151575 · Dynarex Corporation
LXQ · Cup, Eye · 82d
Cleared Aug 28, 2015
PDO Absorbable Punctum Plug
K150288 · Riverpoint Medical
LZU · Plug, Punctum · 204d
Cleared Aug 28, 2015
Menicon Saline Rinse Solution
K151768 · Menicon Co, Ltd.
LPN · Accessories, Soft Lens Products · 59d
Cleared Aug 18, 2015
Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
K151961 · Volk Optical, Inc.
HJK · Lens, Contact, Polymethylmethacrylate, Diagnostic · 33d
Cleared Aug 17, 2015
Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants
K150986 · Meddev Corporation
MML · Weights, Eyelid, External · 125d

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All categories 2883 LPL Lenses, Soft Contact, Daily Wear 359 HQC Unit, Phacofragmentation 196 HQF Laser, Ophthalmic 141 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 74 HLI Ophthalmoscope, Ac-powered 71 OBO Tomography, Optical Coherence 62 HNO Keratome, Ac-powered 59 MSS Folders And Injectors, Intraocular Lens (iol) 50 HMX Cannula, Ophthalmic 49 NFJ System, Image Management, Ophthalmic 49