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
Mar 02, 2020
Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution
LPN
Accessories, Soft Lens Products
234d
Cleared
Jan 22, 2020
Fundus Camera
HKI
Camera, Ophthalmic, Ac-powered
286d
Cleared
Jan 17, 2020
RxSight Insertion Device
MSS
Folders And Injectors, Intraocular Lens (iol)
93d
Cleared
Jan 14, 2020
Icare ic200
HKY
Tonometer, Manual
335d
Cleared
Jan 14, 2020
MiiS Horus Eye Anterior Camera
HJO
Biomicroscope, Slit-lamp, Ac-powered
57d
Cleared
Dec 23, 2019
MAXReach Laser Probe
HQB
Photocoagulator And Accessories
166d
Cleared
Dec 19, 2019
Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q
HKY
Tonometer, Manual
218d
Cleared
Dec 09, 2019
Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses
LPL
Lenses, Soft Contact, Daily Wear
115d
Cleared
Dec 06, 2019
Intraocular Pressure Tonometer EASYTON
HKX
Tonometer, Ac-powered
290d
Cleared
Dec 05, 2019
Vitra 2
GEX
Powered Laser Surgical Instrument
135d
Cleared
Nov 15, 2019
Ophthalmic Yag Laser System YC-200
HQF
Laser, Ophthalmic
107d
Cleared
Nov 15, 2019
DRSplus
MYC
Ophthalmoscope, Laser, Scanning
102d
Cleared
Nov 01, 2019
LEGION System
HQC
Unit, Phacofragmentation
134d
Cleared
Oct 24, 2019
Tear Pool Dissolvable Punctum Plugs
LZU
Plug, Punctum
262d
Cleared
Oct 22, 2019
LipiFlow Thermal Pulsation System
ORZ
Eyelid Thermal Pulsation System
29d
Cleared
Oct 04, 2019
Bausch + Lomb PreVue Inserter for enVista Preloaded
MSS
Folders And Injectors, Intraocular Lens (iol)
67d
Cleared
Oct 02, 2019
OxySoft (olifilcon C) silicone hydrogel soft contact lens
LPL
Lenses, Soft Contact, Daily Wear
131d
Cleared
Sep 27, 2019
ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
51d
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
Looking for a specific ophthalmic device? Search by device name, K-number or manufacturer.
Search all Ophthalmic 510(k) devices