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
5106
Total
5088
Cleared
170d
Avg (2y)
1976
Since
1292 Ophthalmic devices
Cleared
Sep 26, 2019
Spectralis HRA+OCT and Variants
OBO
Tomography, Optical Coherence
23d
Cleared
Sep 25, 2019
EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)
HQC
Unit, Phacofragmentation
174d
Cleared
Sep 17, 2019
UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
60d
Cleared
Sep 13, 2019
Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
260d
Cleared
Sep 13, 2019
UNFOLDER Vitan Inserter
MSS
Folders And Injectors, Intraocular Lens (iol)
53d
Cleared
Sep 10, 2019
KOWA nonmyd 8
HKI
Camera, Ophthalmic, Ac-powered
50d
Cleared
Sep 06, 2019
Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc P for Presbyopia (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc A for Astigmatism (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc AP (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
133d
Cleared
Aug 16, 2019
COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal
HQC
Unit, Phacofragmentation
28d
Cleared
Aug 13, 2019
xPORT Lens Fragmentation System
HQC
Unit, Phacofragmentation
117d
Cleared
Aug 08, 2019
REFRESH RELIEVA For CONTACTS
LPN
Accessories, Soft Lens Products
146d
Cleared
Jul 31, 2019
P200TxE
OBO
Tomography, Optical Coherence
132d
Cleared
Jul 31, 2019
AOCup Lens Case with AODisc
LPN
Accessories, Soft Lens Products
28d
Cleared
Jul 25, 2019
Galilei G6 Lens Professional
MXK
Device, Analysis, Anterior Segment
303d
Cleared
Jul 24, 2019
Canon OCT-A1
OBO
Tomography, Optical Coherence
274d
Cleared
Jul 24, 2019
MaxiTears Contacts PF
MRC
Products, Contact Lens Care, Rigid Gas Permeable
268d
Cleared
Jul 18, 2019
Huvitz Imaging System
NFJ
System, Image Management, Ophthalmic
30d
Cleared
Jun 25, 2019
CLARUS
QER
Camera, Ophthalmic, Slit-scanning
53d
Cleared
Jun 21, 2019
MiiS Horus Scope DPT 100
HKX
Tonometer, Ac-powered
406d
Cleared
Jun 04, 2019
KOWA DR-1a
HKI
Camera, Ophthalmic, Ac-powered
90d
Cleared
May 24, 2019
LightLas Pattern Scanning System - TruScan Pro
HQF
Laser, Ophthalmic
88d
Cleared
May 16, 2019
Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac
LPL
Lenses, Soft Contact, Daily Wear
230d
Cleared
May 16, 2019
ARGOS
MXK
Device, Analysis, Anterior Segment
27d
Cleared
May 03, 2019
Leaf Photocoagulator
HQF
Laser, Ophthalmic
106d
Cleared
May 01, 2019
Vitreq disposable laser probes, light fibers and Chandelier
HQB
Photocoagulator And Accessories
219d
Cleared
Apr 29, 2019
MyDay
LPL
Lenses, Soft Contact, Daily Wear
17d
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