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
2881 Ophthalmic devices
Cleared
Sep 20, 2017
Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)
HQD
Lens, Contact (other Material) - Daily
50d
Cleared
Sep 18, 2017
Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan (hioxifilcon A) Daily Wear Soft (Hydrophilic) Contact Lens for PRESBYOPIA
LPL
Lenses, Soft Contact, Daily Wear
231d
Cleared
Sep 15, 2017
Phoenix Clinical ICON
HKI
Camera, Ophthalmic, Ac-powered
205d
Cleared
Sep 06, 2017
MicroSTAAR Injector System Cartridges
MSS
Folders And Injectors, Intraocular Lens (iol)
30d
Cleared
Aug 25, 2017
Catalys Precision Laser System
OOE
Ophthalmic Femtosecond Laser
53d
Cleared
Aug 16, 2017
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B)
HQD
Lens, Contact (other Material) - Daily
48d
Cleared
Aug 10, 2017
LENSAR Laser System – fs 3D (LLS-fs 3D)
OOE
Ophthalmic Femtosecond Laser
94d
Cleared
Aug 09, 2017
DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal
LPL
Lenses, Soft Contact, Daily Wear
33d
Cleared
Aug 08, 2017
Ahmed Glaucoma Valve Model FP8
KYF
Implant, Eye Valve
83d
Cleared
Aug 01, 2017
HEXA100 (hexafocon A) Daily Wear Contact Lenses
HQD
Lens, Contact (other Material) - Daily
112d
Cleared
Jul 27, 2017
VISCO 360 Viscosurgical System
MRH
Pump, Infusion, Ophthalmic
31d
Cleared
Jul 25, 2017
Easyret
HQF
Laser, Ophthalmic
197d
Cleared
Jul 21, 2017
Portable Slit Lamp Microscope
HJO
Biomicroscope, Slit-lamp, Ac-powered
294d
Cleared
Jul 17, 2017
BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)
HQD
Lens, Contact (other Material) - Daily
66d
Cleared
Jul 14, 2017
Contact Lens Case
LRX
Case, Contact Lens
49d
Cleared
Jun 27, 2017
Contact Lens Case Round Glasses
LRX
Case, Contact Lens
68d
Cleared
Jun 23, 2017
YELLOW LASER PHOTOCOAGULATOR YLC-500
HQF
Laser, Ophthalmic
143d
Cleared
Jun 21, 2017
PRIMUS
OBO
Tomography, Optical Coherence
218d
Cleared
Jun 21, 2017
Retina Workplace
NFJ
System, Image Management, Ophthalmic
111d
Cleared
Jun 15, 2017
Katalyst Cyclophotocoagulation Probe
LQJ
Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
175d
Cleared
Jun 09, 2017
iVue
OBO
Tomography, Optical Coherence
179d
Cleared
Jun 06, 2017
Altomed Malhotra Platinum Segments
MML
Weights, Eyelid, External
98d
Cleared
Jun 02, 2017
Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens
HQD
Lens, Contact (other Material) - Daily
150d
Cleared
Jun 02, 2017
Zepto
PUL
Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-powered
91d
Cleared
Jun 02, 2017
PolyDev Soft Contact Lenses
LPL
Lenses, Soft Contact, Daily Wear
43d
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