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
Jan 19, 2018
DRI OCT Triton
OBO
Tomography, Optical Coherence
112d
Cleared
Dec 26, 2017
iLux Instrument, iLux Disposable
ORZ
Eyelid Thermal Pulsation System
116d
Cleared
Dec 21, 2017
SLM-1ER, SLM-2ER, SLM-3ER
HJO
Biomicroscope, Slit-lamp, Ac-powered
181d
Cleared
Dec 21, 2017
OMNI Surgical System
MRH
Pump, Infusion, Ophthalmic
59d
Cleared
Dec 15, 2017
pioli IOL Delivery System
MSS
Folders And Injectors, Intraocular Lens (iol)
143d
Cleared
Dec 13, 2017
Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
98d
Cleared
Dec 11, 2017
Crystalsert Lens Delivery System
MSS
Folders And Injectors, Intraocular Lens (iol)
28d
Cleared
Dec 05, 2017
OxyPure Color Silicone Hydrogel Soft Contact Lenses
LPL
Lenses, Soft Contact, Daily Wear
203d
Cleared
Dec 04, 2017
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
LRX
Case, Contact Lens
19d
Cleared
Nov 30, 2017
Contact Lens Case, Model: A-1, B-1
LRX
Case, Contact Lens
66d
Cleared
Nov 27, 2017
PSLT for PASCAL Streamline
HQF
Laser, Ophthalmic
189d
Cleared
Nov 27, 2017
Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions
MRC
Products, Contact Lens Care, Rigid Gas Permeable
59d
Cleared
Nov 17, 2017
Bausch + Lomb Boston Scleral Lens Case
LRX
Case, Contact Lens
22d
Cleared
Nov 16, 2017
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
MRC
Products, Contact Lens Care, Rigid Gas Permeable
48d
Cleared
Nov 07, 2017
NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
LPL
Lenses, Soft Contact, Daily Wear
39d
Cleared
Nov 01, 2017
IMAGEnet 6 Ophthalmic Data System
NFJ
System, Image Management, Ophthalmic
175d
Cleared
Nov 01, 2017
Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor
OBO
Tomography, Optical Coherence
57d
Cleared
Oct 26, 2017
EPI K Console
HNO
Keratome, Ac-powered
29d
Cleared
Oct 25, 2017
AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal
LPL
Lenses, Soft Contact, Daily Wear
56d
Cleared
Oct 24, 2017
ENFLU 18 (enflufocon A) Daily Wear Contact Lens
HQD
Lens, Contact (other Material) - Daily
147d
Cleared
Oct 19, 2017
VICTUS Femtosecond Laser Platform
OOE
Ophthalmic Femtosecond Laser
198d
Cleared
Oct 18, 2017
Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
184d
Cleared
Oct 17, 2017
Applanation tonometer AT-1
HKY
Tonometer, Manual
36d
Cleared
Oct 06, 2017
Digital Eye Anterior Camera
HJO
Biomicroscope, Slit-lamp, Ac-powered
232d
Cleared
Sep 27, 2017
Cetus system, Cetus probe
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
247d
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