Ophthalmic

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Code	Device name	Class	21 CFR	510(k) (3y)
LPO	Gases Used Within Eye To Place Pressure On Detached Retina	Class 3	21 CFR 886.4270
LQJ	Lens, Surgical, Laser, Accesssory, Ophthalmic Laser	Class 2	21 CFR 886.4390	13
LRX	Case, Contact Lens	Class 2	21 CFR 886.5928	82
LWL	Fluid, Intraocular	Class 3	21 CFR 886.4275	1
LXP	Plug, Scleral	Class 2	21 CFR 886.4155	10
LXS	Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting	Class 2	21 CFR 886.4392	6
LYL	Accessories, Solution, Ultrasonic Cleaners For Lenses	Class 2	21 CFR 886.5928	22
LZP	Aid, Surgical, Viscoelastic	Class 3	21 CFR 886.4275
LZR	Ultrasound, Cyclodestructive	Class 2	21 CFR 886.5350
MFK	Lens, Multifocal Intraocular	Class 3	21 CFR 886.3600
MJP	Lens, Intraocular, Toric Optics	Class 3	21 CFR 886.3600
MLP	Keratoprosthesis, Temporary Implant, Surgical Use	Class 2	21 CFR 886.3400	5
MLZ	Vitrectomy, Instrument Cutter	Class 2	21 CFR 886.4150	4
MMC	Dilator, Expansive Iris (Accessory)	Class 2	21 CFR 886.4150
MMF	Photorefractor	Class 2	21 CFR 886.1120	1
MML	Weights, Eyelid, External	Class 2	21 CFR 886.5700	14
MMQ	Topographer, Corneal, Ac-Powered	Class 1	21 CFR 886.1350	5
MOE	Collagen Corneal Shield	Class 1	21 CFR 886.4750	19
MQU	Ocular Peg	Class 2	21 CFR 886.3320	4
MRC	Products, Contact Lens Care, Rigid Gas Permeable	Class 2	21 CFR 886.5918	33
MSG	Ophthalmoscopes, Replacement Batteries, Hand-Held	Class 2	21 CFR 886.1570	2
MSR	Tubing, Replacement, Phacofragmentation Unit	Class 2	21 CFR 886.4150	5
MSS	Folders And Injectors, Intraocular Lens (Iol)	Class 1	21 CFR 886.4300	63
MTZ	Wrap, Implant, Orbital	Class 2	21 CFR 886.3320	2
MUS	Fluidic, Phacoemulsification/Phacofragmentation	Class 2	21 CFR 886.4670	1
MUW	Lens, Contact (Orthokeratology)	Class 2	21 CFR 886.5916	6
MVN	Lens, Contact, (Disposable)	Class 2	21 CFR 886.5925	26
MWL	Lens, Contact (Rigid Gas Permeable), Extended Wear	Class 3	21 CFR 886.5916
MXK	Device, Analysis, Anterior Segment	Class 2	21 CFR 886.1850	23
MXO	Laser, System, Phacolysis	Class 2	21 CFR 886.4670
MXY	Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal	Class 1	21 CFR 886.4350
MYC	Ophthalmoscope, Laser, Scanning	Class 2	21 CFR 886.1570	22
MYD	Keratome, Water Jet	Class 1	21 CFR 886.4370	1
MZD	System, In-Office Tinting, Contact Lenses	Class 2	21 CFR 886.5925	1
NAA	Lens, Intraocular, Accommodative	Class 3	21 CFR 886.3600
NAI	Lens, Prescription, Color Deficiency	Class 1	21 CFR 886.5844	1
NCB	Weights, Eyelid, Implantable	Class 2	21 CFR 886.5700	1
NCE	Injector, Capsular Tension Ring	Class 1	21 CFR 886.4300	3
NCF	Aberrometer, Ophthalmic	Class 1	21 CFR 886.1760	4
NCK	Button, Iris, Eye, Artificial	Class 1	21 CFR 886.3200	1
NCR	Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered	Class 2	21 CFR 886.4100	3
NCZ	Lens, Contact, For Color Vision Deficiency	Class 2	21 CFR 886.5925	1
NFD	Selector, Color, Spectacle, Lens, Tint	Class 1	21 CFR 886.1160	1
NFM	Expander, Tissue, Orbital	Class 2	21 CFR 886.3320	2
NGY	Cannula, Trocar, Ophthalmic	Class 1	21 CFR 886.4350	1
NIC	Lens, Contact, For Reading Discomfort	Class 2	21 CFR 886.5925	1
NIZ	Lens, Iris Reconstruction	Class 3	21 CFR 886.3600
NJG	Flasher, Afterimage, Ophthalmic	Class 2	21 CFR 886.1300
NJH	Lens, Spectacle (Prescription), For Reading Discomfort	Class 1	21 CFR 886.5844	2
NJJ	Tonometer, Analyzer, Ocular Blood Flow	Class 2	21 CFR 886.1930	1
NKX	Needle, Phacoemulsification, Reprocessed	Class 2	21 CFR 886.4670	5
NKY	Blade, Keratome, Reprocessed	Class 1	21 CFR 886.4370
NLA	Knife, Ophthalmic, Reprocessed	Class 1	21 CFR 886.4350
NOG	Topographer, Corneal, Battery Powered	Class 1	21 CFR 886.1350
NOH	Photokeratoscope, Battery Powered	Class 1	21 CFR 886.1350
NOI	Stand, Instrument, Ophthalmic, Battery Powered	Class 1	21 CFR 886.1860
NPB	System, Monitoring, For Progress Of Labor	Class 2	21 CFR 884.2800	4
NQB	Conformer, Ophthalmic, Biological Tissue	Class 2	21 CFR 886.3130	1
NQE	Microscope, Specular	Class 2	21 CFR 886.1850	9
NUU	Lens, Contact, Orthokeratology, Overnight	Class 3	21 CFR 886.5916
NVB	Intraocular, Pressure Measuring Device	Class 3	21 CFR 886.4280
NXM	Prosthesis, Eyelid Spacer/Graft, Biologic	Class 2	21 CFR 886.3130	2
NXR	Fixation, Vision Training, Binocular	Class 1	21 CFR 886.1290	1
NYK	Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate	Class 2	21 CFR 886.1385	1
OBO	Tomography, Optical Coherence	Class 2	21 CFR 886.1570	66
OHW	Burr, Corneal, Battery Powered, Rust Ring Removal	Class 1	21 CFR 886.4070
OHX	Burr, Corneal, Ac-Powered, Rust Ring Removal	Class 1	21 CFR 886.4070
OJK	Eye Tray	Class 2	21 CFR 886.4790
OOE	Ophthalmic Femtosecond Laser	Class 2	21 CFR 886.4390	47
OPT	Infrared Hematoma Detector	Class 2	21 CFR 882.1935	5
ORZ	Eyelid Thermal Pulsation System	Class 2	21 CFR 886.5200	13
OTZ	Graft Insertion Instrument For Endothelial Keratoplasty	Class 1	21 CFR 886.4300	5
OUM	Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimu	Class 1	21 CFR 886.1050	1
PIB	Diabetic Retinopathy Detection Device	Class 2	21 CFR 886.1100	8
PIC	Oral Electronic Vision Aid	Class 2	21 CFR 886.5905	2
PJZ	Camera, Ophthalmic, General-Use	Class 2	21 CFR 886.1120
PLX	Tear Duct Occluder	Class 1	21 CFR 886.5838	1
PLZ	Ocular Pattern Recorder	Class 2	21 CFR 886.1925	1
PMW	Strabismus Detection Device	Class 2	21 CFR 886.1342	1
POE	Extended Depth Of Focus Intraocular Lens	Class 3	21 CFR 886.3600
PQJ	Intranasal Electrostimulation Device	Class 2	21 CFR 886.5300	1
PUE	Biomicroscope, Slit-Lamp, Ac-Powered, Exempt	Class 2	21 CFR 886.1850
PUF	Ocular Peg, Exempt	Class 2	21 CFR 886.3320
PUL	Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered	Class 2	21 CFR 886.4100	4
PZG	Surgical Eye Tray	Class 1	21 CFR 886.4350
PZK	Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)	Class 3	21 CFR 886.3600
QBR	Intranasal Electrostimulation Device For Dry Eye Symptoms	Class 2	21 CFR 886.5310	2
QCB	Phakic Toric Intraocular Lens	Class 3	21 CFR 886.3600
QCW	Corneal Storage Media With Preservatives Including Anti-Fungal	Class 2	21 CFR 886.4320	1
QDV	Iol Tray	Class 1	21 CFR 886.4350
QDW	Phaco Kit	Class 2	21 CFR 886.4670
QDY	Vitrectomy Kit	Class 2	21 CFR 886.4150
QER	Camera, Ophthalmic, Slit-Scanning	Class 2	21 CFR 886.1120	3
QGJ	Corneal Inlay Inserter Handle	Class 1	21 CFR 886.4355
QIU	Intense Pulsed Light Device For Managing Dry Eye	Class 2	21 CFR 886.5201	1
QKV	Electromechanical Tear Stimulator	Class 2	21 CFR 886.5305	2
QMM	Hydrophilic Re-Coating Solution	Class 2	21 CFR 886.5919	1
QQJ	Applicator, Negative Pressure, External, Ocular	Class 2	21 CFR 886.5000	2
QQQ	Guide And Positioner, Ophthalmic Drug Delivery Device	Class 1	21 CFR 886.4300
QQU	Digital Therapy Device For Amblyopia	Class 2	21 CFR 886.5500	5
QTO	Digital Visual Acuity Test	Class 1	21 CFR 886.1150	1
QTW	Digital Amsler Grid	Class 1	21 CFR 886.1330	1
QUR	Prescription Spectacle Lenses To Reduce The Progression Of Myopia	Class 2	21 CFR 886.5845	1
QWU	Prosthesis, Eyelid Spacer/Graft, Polymer	Class 2	21 CFR 886.3130	1
QZP	Camera, Ophthalmic, Non-Prescription	Class 2	21 CFR 886.1120
SAX	Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging	Class 2	21 CFR 886.1600	1
SBI	Manual Refractor, 3d Display	Class 1	21 CFR 886.1770	1
SBN	Digital Therapy Device For Convergence Insufficiency	Class 1	21 CFR 886.1290	1
SCW	Digital Prismatic Correction	Class 1	21 CFR 886.1655	2
SDE	Light Based Device For Dry Age-Related Macular Degeneration	Class 2	21 CFR 886.5520	1