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
Jun 14, 2021
CATS®-D Tonometer Prism
HKY
Tonometer, Manual
165d
Cleared
Jun 11, 2021
Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants
NCB
Weights, Eyelid, Implantable
186d
Cleared
Jun 10, 2021
IDx-DR
PIB
Diabetic Retinopathy Detection Device
181d
Cleared
May 28, 2021
ABT12 multi-purpose solution
LPN
Accessories, Soft Lens Products
241d
Cleared
May 26, 2021
OTE MPS 045 Multi-purpose Lens Care Solution
LPN
Accessories, Soft Lens Products
138d
Cleared
May 24, 2021
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
LPL
Lenses, Soft Contact, Daily Wear
53d
Cleared
May 11, 2021
Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A)
HQD
Lens, Contact (other Material) - Daily
225d
Cleared
Apr 27, 2021
AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
57d
Cleared
Apr 26, 2021
MicroDose Injector
FMF
Syringe, Piston
172d
Cleared
Apr 13, 2021
RetCam Envision
HKI
Camera, Ophthalmic, Ac-powered
134d
Cleared
Apr 13, 2021
NFC-600 Automated Portable Retinal Camera
HKI
Camera, Ophthalmic, Ac-powered
78d
Cleared
Apr 12, 2021
Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere
LPL
Lenses, Soft Contact, Daily Wear
59d
Cleared
Apr 09, 2021
Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
HQD
Lens, Contact (other Material) - Daily
123d
Cleared
Apr 07, 2021
CATALYS Precision Laser System
OOE
Ophthalmic Femtosecond Laser
29d
Cleared
Apr 01, 2021
Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo
LPL
Lenses, Soft Contact, Daily Wear
244d
Cleared
Apr 01, 2021
VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System
LYL
Accessories, Solution, Ultrasonic Cleaners For Lenses
57d
Cleared
Mar 12, 2021
VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control
HQC
Unit, Phacofragmentation
155d
Cleared
Mar 11, 2021
Ritleng®+ and Ritleng®+ PVP
OKS
Lacrimal Stents And Intubation Sets
246d
Cleared
Mar 01, 2021
OMNI Surgical System
MRH
Pump, Infusion, Ophthalmic
167d
Not Cleared
Feb 23, 2021
Lumenis Stellar M22
QIU
Intense Pulsed Light Device For Managing Dry Eye
309d
Cleared
Feb 02, 2021
Fundus Camera
HKI
Camera, Ophthalmic, Ac-powered
188d
Cleared
Jan 29, 2021
VX650
HKI
Camera, Ophthalmic, Ac-powered
176d
Cleared
Dec 30, 2020
CryoTreQ
HPS
Unit, Cryophthalmic
160d
Cleared
Dec 24, 2020
Image Quality Analyzer (IQA)
NFJ
System, Image Management, Ophthalmic
308d
Cleared
Dec 18, 2020
LacriJet®
OKS
Lacrimal Stents And Intubation Sets
186d
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