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 16, 2018
FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG
HQD
Lens, Contact (other Material) - Daily
53d
Cleared
Mar 16, 2018
Frigitronics adapter
HRN
Unit, Cryophthalmic, Ac-powered
51d
Cleared
Mar 14, 2018
Specular Microscope CEM-530
NQE
Microscope, Specular
75d
Cleared
Mar 09, 2018
CATS Tonometer Prism
HKY
Tonometer, Manual
77d
Cleared
Mar 02, 2018
LENSAR Laser System - fs 3D (LLS-fs 3D)
OOE
Ophthalmic Femtosecond Laser
128d
Cleared
Feb 28, 2018
P200TE
OBO
Tomography, Optical Coherence
86d
Cleared
Feb 23, 2018
Ophthalmic Software Platform RX
NFJ
System, Image Management, Ophthalmic
84d
Cleared
Feb 22, 2018
Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
51d
Cleared
Jan 19, 2018
EM-4000 Specular Microscope
NQE
Microscope, Specular
260d
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
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