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 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
Cleared
May 31, 2017
SL 220
HJO
Biomicroscope, Slit-lamp, Ac-powered
247d
Cleared
May 31, 2017
Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens
HQD
Lens, Contact (other Material) - Daily
148d
Cleared
May 19, 2017
SLIT LAMP SL-2000
HJO
Biomicroscope, Slit-lamp, Ac-powered
151d
Cleared
May 19, 2017
Catalys Precision Laser System
OOE
Ophthalmic Femtosecond Laser
107d
Cleared
May 05, 2017
LENSAR Laser System - fs 3D (LLS-fs 3D)
OOE
Ophthalmic Femtosecond Laser
67d
Cleared
May 03, 2017
PHAKOS Disposable Retinal Cryo Probe
HRN
Unit, Cryophthalmic, Ac-powered
215d
Cleared
May 02, 2017
AXIS Image Management System
NFJ
System, Image Management, Ophthalmic
19d
Cleared
Apr 24, 2017
VX130 Ophthalmic Diagnostic Device
HKX
Tonometer, Ac-powered
272d
Not Cleared
Apr 24, 2017
Oculeve Intranasal Tear Neurostimulator Device
PQJ
Intranasal Electrostimulation Device
291d
Cleared
Apr 19, 2017
Stellaris Elite vision enhancement system
HQC
Unit, Phacofragmentation
104d
Cleared
Apr 18, 2017
Lacriflow CL
OKS
Lacrimal Stents And Intubation Sets
81d
Cleared
Apr 17, 2017
Soft Plug Extended Duration 180 Canalicular Plug
LZU
Plug, Punctum
237d
Cleared
Apr 14, 2017
CENTURION Vision System (Active SentryTM)
HQC
Unit, Phacofragmentation
288d
Cleared
Apr 14, 2017
Marco Ultra M3, Marco Ultra M4
HJO
Biomicroscope, Slit-lamp, Ac-powered
205d
Cleared
Apr 11, 2017
HAAG-STREIT FUNDUS MODULE 300
HKI
Camera, Ophthalmic, Ac-powered
162d
Cleared
Apr 11, 2017
Bausch + Lomb Sensitive Eyes Plus Saline Solution
LPN
Accessories, Soft Lens Products
54d
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