FDA Device Explorer

Ophthalmic (OP) FDA Submissions

Browse FDA 510(k), De Novo, and PMA medical device clearances for the Ophthalmic (OP) review panel, including product codes, regulations, and cleared devices.

CFR Parts: Part 882, Part 884, Part 886, Part 892

Subparts

Product Codes

Product CodeDevice NameRegulationClassDevices
OPTInfrared Hematoma Detector882.193525
NPBSystem, Monitoring, For Progress Of Labor884.280024
HJCEsthesiometer, Ocular886.104012
HJWAdaptometer (Biophotometer)886.105010
OUMAdaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation886.105011
HIWAnomaloscope886.107013
HIYBrush, Haidinger, (Including Macular Integrity)886.109010
PIBDiabetic Retinopathy Detection Device886.110027
HKICamera, Ophthalmic, Ac-Powered886.11202156
MMFPhotorefractor886.112021
PJZCamera, Ophthalmic, General-Use886.112020
QERCamera, Ophthalmic, Slit-Scanning886.112023
QZPCamera, Ophthalmic, Non-Prescription886.112020
HMDChair, Ophthalmic, Manual886.114011
HMEChair, Ophthalmic, Ac-Powered886.1140116
HOXChart, Visual Acuity886.1150132
QTODigital Visual Acuity Test886.115011
HJDIlluminator, Color Vision Plate886.116011
NFDSelector, Color, Spectacle, Lens, Tint886.116011
HITTester, Color Vision886.117019
HMMDistometer886.119012
HOWDrum, Opticokinetic886.120011
HLZElectrode, Corneal886.1220211
HMKEuthyscope, Ac-Powered886.125020
HMLEuthyscope, Battery-Powered886.125010
HLSExophthalmometer886.127011
HPLDevice, Fixation, Ac-Powered, Ophthalmic886.129017
NXRFixation, Vision Training, Binocular886.129011
SBNDigital Therapy Device For Convergence Insufficiency886.129011
NJGFlasher, Afterimage, Ophthalmic886.130020
HKGFornixscope886.132010
HOQGrid, Amsler886.133018
QTWDigital Amsler Grid886.133011
HJTHaploscope886.134012
PMWStrabismus Detection Device886.134221
HJAPhotokeratoscope886.135015
HLQKeratoscope, Ac-Powered886.1350129
HLRKeratoscope, Battery-Powered886.135017
MMQTopographer, Corneal, Ac-Powered886.135015
NOGTopographer, Corneal, Battery Powered886.135010
NOHPhotokeratoscope, Battery Powered886.135010
HPJInstrument, Visual Field, Laser886.136025
HPDLens, Bagolini886.137510
HJLLens, Condensing, Diagnostic886.138011
HJKLens, Contact, Polymethylmethacrylate, Diagnostic886.1385241
NYKOphthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)886.138521
HJJLens, Fresnel, Flexible, Diagnostic886.139010
HJILens, Fundus, Hruby, Diagnostic886.139518
HKRLens, Maddox886.140010
HPCSet, Lens, Trial, Ophthalmic886.1405113
HPBClip, Lens, Trial, Ophthalmic886.141010
HPAFrame, Trial, Ophthalmic886.141515
HLNGauge, Lens, Ophthalmic886.142012
HLMInstrument, Measuring, Lens, Ac-Powered886.1425116
HLFDevice, Measuring, Lens Radius, Ophthalmic886.143013
HIXMaxwell Spot, Ac-Powered886.143512
HJBInstrument, Measuring, Corneal Radius886.145015
HLCInstrument, Measuring, Stereopsis886.146010
HKFMirror, Headband, Ophthalmic886.150010
HLLMonitor, Eye Movement886.151024
HMCMonitor, Eye Movement, Diagnostic886.151021
HLIOphthalmoscope, Ac-Powered886.1570287
HLJOphthalmoscope, Battery-Powered886.1570247
MSGOphthalmoscopes, Replacement Batteries, Hand-Held886.157022
MYCOphthalmoscope, Laser, Scanning886.1570222
OBOTomography, Optical Coherence886.1570265
SAXHome Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device886.160021
HONPerimeter, Manual886.160510
HOOPerimeter, Ac-Powered886.160516
HPTPerimeter, Automatic, Ac-Powered886.1605141
HLXPhotostimulator, Ac-Powered886.1630218
HLTPreamplifier, Ac-Powered, Ophthalmic886.164024
HLWPreamplifier, Battery-Powered, Ophthalmic886.164023
HKWPrism, Bar, Ophthalmic886.165012
HKTPrism, Fresnel, Ophthalmic886.165510
SCWDigital Prismatic Correction886.165512
HKSPrism, Gonioscopic886.1660110
HKQPrism, Rotary, Ophthalmic886.166510
HPWProbe And Counter, Isotope, For Phosphorus 32886.167020
HOSProjector, Ophthalmic886.168019
HRIPupillograph886.169010
HLGPupillometer, Ac-Powered886.170013
HLHPupillometer, Manual886.170012
HMHRack, Skiascopic886.175012
HKORefractometer, Ophthalmic886.1760135
NCFAberrometer, Ophthalmic886.176014
HKNRefractor, Manual, Non-Powered, Including Phoropter886.177013
SBIManual Refractor, 3d Display886.177011
HKLRetinoscope, Ac-Powered886.178026
HKMRetinoscope, Battery-Powered886.178017
HLERuler, Nearpoint (Punctometer)886.179010
KYDStrip, Schirmer886.180013
HLKScreen, Tangent, Target, Battery-Powered886.181010
HMJScreen, Tangent, Projection, Battery-Powered886.181012
HOJScreen, Tangent, Target886.181013
HOKScreen, Tangent, Projection, Ac-Powered886.181011
HOLScreen, Tangent, Felt (Campimeter)886.181010
HOMScreen, Tangent, Ac-Powered (Campimeter)886.181011
HOPCampimeter, Stereo, Battery-Powered886.181010
HORSimulatan (Including Crossed Cylinder)886.184011
HJOBiomicroscope, Slit-Lamp, Ac-Powered886.18502108
MXKDevice, Analysis, Anterior Segment886.1850223
NQEMicroscope, Specular886.185029
PUEBiomicroscope, Slit-Lamp, Ac-Powered, Exempt886.185020
HMFStand, Instrument, Ac-Powered, Ophthalmic886.1860115
HMGStand, Instrument, Ophthalmic, Non-Powered886.186014
HRECabinet, Instrument, Ac-Powered, Ophthalmic886.186010
NOIStand, Instrument, Ophthalmic, Battery Powered886.186010
HJQStereoscope, Ac-Powered886.187011
HJRStereoscope, Battery-Powered886.187010
HLPTarget, Fusion And Stereoscopic886.188013
HKDTape, Nystagmus886.190510
HJSTest, Spectacle Dissociation, Ac-Powered (Lancaster)886.191010
HLOTest, Spectacle Dissociation, Battery-Powered (Lancaster)886.191010
PLZOcular Pattern Recorder886.192521
HKXTonometer, Ac-Powered886.1930258
HKYTonometer, Manual886.1930256
HLACalibrator, Tonometer886.193020
HPKTonograph886.193020
NJJTonometer, Analyzer, Ocular Blood Flow886.193021
HKZSterilizer, Tonometer886.194010
HJMTransilluminator, Ac-Powered886.1945212
HJNTransilluminator, Battery-Powered886.194513
HQWClip, Tantalum, Ophthalmic886.310023
HQNConformer, Ophthalmic886.313027
NQBConformer, Ophthalmic, Biological Tissue886.313021
NXMProsthesis, Eyelid Spacer/Graft, Biologic886.313022
QWUProsthesis, Eyelid Spacer/Graft, Polymer886.313021
HQHEye, Artificial, Non-Custom886.320016
NCKButton, Iris, Eye, Artificial886.320011
HQJImplant, Absorbable, (Scleral Buckling Methods)886.330025
HPZImplant, Eye Sphere886.3320239
MQUOcular Peg886.332024
MTZWrap, Implant, Orbital886.332022
NFMExpander, Tissue, Orbital886.332022
PUFOcular Peg, Exempt886.332020
HQXImplant, Orbital, Extra-Ocular886.3340216
HQMKeratoprosthesis, Permanent Implant886.340024
MLPKeratoprosthesis, Temporary Implant, Surgical Use886.340024
HQLIntraocular Lens886.3600365
MFKLens, Multifocal Intraocular886.360035
MJPLens, Intraocular, Toric Optics886.360030
NAALens, Intraocular, Accommodative886.360031
NIZLens, Iris Reconstruction886.360030
POEExtended Depth Of Focus Intraocular Lens886.360031
PZKLight Adjustable Lens (Lal) And Light Delivery Device (Ldd)886.360031
QCBPhakic Toric Intraocular Lens886.360030
HQTShell, Scleral886.380024
KYFImplant, Eye Valve886.3920225
HLDEngine, Trephine, Accessories, Gas-Powered886.407010
HOGBurr, Corneal, Battery-Powered886.407015
HQSBurr, Corneal, Ac-Powered886.407011
HRFEngine, Trephine, Accessories, Battery-Powered886.407010
HRGEngine, Trephine, Accessories, Ac-Powered886.407016
OHWBurr, Corneal, Battery Powered, Rust Ring Removal886.407010
OHXBurr, Corneal, Ac-Powered, Rust Ring Removal886.407010
HQQApparatus, Cautery, Radiofrequency, Battery-Powered886.410023
HQRApparatus, Cautery, Radiofrequency, Ac-Powered886.4100211
NCRApparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered886.410023
PULApparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered886.410024
HQOUnit, Cautery, Thermal, Ac-Powered886.4115212
HQPUnit, Cautery, Thermal, Battery-Powered886.4115224
HKPInstrument, Vitreous Aspiration And Cutting, Battery-Powered886.4150216
HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered886.41502149
MLZVitrectomy, Instrument Cutter886.415024
MMCDilator, Expansive Iris (Accessory)886.415020
MSRTubing, Replacement, Phacofragmentation Unit886.415025
QDYVitrectomy Kit886.415020
LXPPlug, Scleral886.4155210
HPSUnit, Cryophthalmic886.4170211
HQAUnit, Cryotherapy, Ophthalmic886.417024
HRNUnit, Cryophthalmic, Ac-Powered886.4170210
HMSDrum, Eye Knife Test886.423011
HPYUnit, Electrolysis, Battery-Powered, Ophthalmic886.425011
HROUnit, Electrolysis, Ac-Powered, Ophthalmic886.425020
LPOGases Used Within Eye To Place Pressure On Detached Retina886.427034
LWLFluid, Intraocular886.427535
LZPAid, Surgical, Viscoelastic886.4275313
NVBIntraocular, Pressure Measuring Device886.428030
KYBLens, Guide, Intraocular886.4300139
MSSFolders And Injectors, Intraocular Lens (Iol)886.4300162
NCEInjector, Capsular Tension Ring886.430013
OTZGraft Insertion Instrument For Endothelial Keratoplasty886.430015
QQQGuide And Positioner, Ophthalmic Drug Delivery Device886.430010
QCWCorneal Storage Media With Preservatives Including Anti-Fungal886.432021
FCTHeadlight, Fiberoptic Focusing886.433526
FSRLight, Headband, Surgical886.433524
HPPHeadlamp, Operating, Battery-Operated886.433510
HPQHeadlamp, Operating, Ac-Powered886.433525
HMXCannula, Ophthalmic886.4350177
HMZTrabeculotome886.435010
HNASpud, Ophthalmic886.435012
HNBSpoon, Ophthalmic886.435010
HNCSpecula, Ophthalmic886.4350111
HNDSpatula, Ophthalmic886.435016
HNESnare, Enucleating886.435010
HNFScissors, Ophthalmic886.4350115
HNGRongeur, Lachrymal Sac886.435010
HNHRing, Ophthalmic (Flieringa)886.435017
HNIRetractor, Ophthalmic886.435012
HNJPunch, Corneo-Scleral886.435013
HNKProbe, Trabeculotomy886.435010
HNLProbe, Lachrymal886.4350110
HNMNeedle, Ophthalmic Suturing886.435012
HNNKnife, Ophthalmic886.4350154
HNPIntroducer, Sphere886.435010
HNQHook, Ophthalmic886.4350110
HNRForceps, Ophthalmic886.4350144
HNSExpressor886.435010
HNTErisophake886.435010
HNWDilator, Lachrymal886.435013
HNXDepressor, Orbital886.435012
HNYCystotome886.4350120
HNZCurette, Ophthalmic886.435012
HOACompressor, Orbital886.435010
HOBClamp, Muscle, Ophthalmic886.435013
HOCClip, Iris Retractor886.435012
HODClamp, Eyelid, Ophthalmic886.435013
HOECaliper, Ophthalmic886.435017
HOFBurr, Corneal, Manual886.435011
HRHTrephine, Manual, Ophthalmic886.4350112
MXYCannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal886.435010
NGYCannula, Trocar, Ophthalmic886.435011
NLAKnife, Ophthalmic, Reprocessed886.435010
PZGSurgical Eye Tray886.435010
QDVIol Tray886.435010
QGJCorneal Inlay Inserter Handle886.435510
KYGDevice, Irrigation, Ocular Surgery886.4360140
HMYKeratome, Battery-Powered886.4370112
HNOKeratome, Ac-Powered886.4370183
MYDKeratome, Water Jet886.437011
NKYBlade, Keratome, Reprocessed886.437010
HQFLaser, Ophthalmic886.43902180
LQJLens, Surgical, Laser, Accesssory, Ophthalmic Laser886.4390213
OOEOphthalmic Femtosecond Laser886.4390247
LXSLaser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla886.439227
HPMLocator, Metal, Electronic886.440024
HPOMagnet, Ac-Powered886.444023
FTZLocator, Magnetic886.444512
HPNMagnet, Permanent886.444515
HMQMarker, Sclera886.457010
HMRMarker, Ocular886.457015
HRPPen, Marking, Surgical886.457010
LCCApplicator, Ocular Pressure886.461026
HQCUnit, Phacofragmentation886.46702315
MUSFluidic, Phacoemulsification/Phacofragmentation886.467021
MXOLaser, System, Phacolysis886.467020
NKXNeedle, Phacoemulsification, Reprocessed886.467025
QDWPhaco Kit886.467020
HQBPhotocoagulator And Accessories886.4690230
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)886.4750155
MOECollagen Corneal Shield886.4750119
HOHSpectacle, Operating (Loupe), Ophthalmic886.477013
HOZSponge, Ophthalmic886.4790247
OJKEye Tray886.479020
HRJTable, Instrument, Powered, Ophthalmic886.485517
HRKTable, Instrument, Manual, Ophthalmic886.485512
QQJApplicator, Negative Pressure, External, Ocular886.500021
HRLUnit, Beta, Radiation, Ophthalmic886.510020
HJHLoupe, Binocular, Low Power886.512013
ORZEyelid Thermal Pulsation System886.5200211
QIUIntense Pulsed Light Device For Managing Dry Eye886.520121
PQJIntranasal Electrostimulation Device886.530021
QKVElectromechanical Tear Stimulator886.530522
QBRIntranasal Electrostimulation Device For Dry Eye Symptoms886.531022
LZRUltrasound, Cyclodestructive886.535021
KYEInserter/Remover Contact Lens886.5420112
QQUDigital Therapy Device For Amblyopia886.550025
SDELight Based Device For Dry Age-Related Macular Degeneration886.552021
HJFMagnifier, Hand-Held, Low-Vision886.554011
HKCSpectacle Microscope, Low-Vision886.554011
HJZCrutch, Ptosis886.560010
MMLWeights, Eyelid, External886.5700214
NCBWeights, Eyelid, Implantable886.570021
HJYReader, Bar, Ophthalmic886.580011
HJXReader, Prism, Ophthalmic886.581011
HJGSystem, Reading, Television, Closed-Circuit886.582018
PLXTear Duct Occluder886.583811
HOISpectacle, Magnifying886.5840111
HQZFrame, Spectacle886.58421198
HQGLens, Spectacle, Non-Custom (Prescription)886.5844156
NAILens, Prescription, Color Deficiency886.584411
NJHLens, Spectacle (Prescription), For Reading Discomfort886.584412
QURPrescription Spectacle Lenses To Reduce The Progression Of Myopia886.584521
HQYSunglasses (Non-Prescription Including Photosensitive)886.58501646
HKBTelescope, Hand-Held, Low-Vision886.587010
HKKTelescope, Spectacle, Low-Vision886.587012
HPFAid, Vision, Electronic, Ac-Powered886.590011
HPGAid, Vision, Electronic, Battery-Powered886.590017
PICOral Electronic Vision Aid886.590522
HOTAid, Vision Image Intensification886.591012
HPEAid, Vision, Optical, Battery-Powered886.591511
HPIAid, Vision, Optical, Ac-Powered886.591510
HQDLens, Contact (Other Material) - Daily886.59162120
MUWLens, Contact (Orthokeratology)886.591626
MWLLens, Contact (Rigid Gas Permeable), Extended Wear886.591636
NUULens, Contact, Orthokeratology, Overnight886.591634
MRCProducts, Contact Lens Care, Rigid Gas Permeable886.5918233
QMMHydrophilic Re-Coating Solution886.591921
LPLLenses, Soft Contact, Daily Wear886.59252490
LPMLenses, Soft Contact, Extended Wear886.5925337
MVNLens, Contact, (Disposable)886.5925225
MZDSystem, In-Office Tinting, Contact Lenses886.592521
NCZLens, Contact, For Color Vision Deficiency886.592521
NICLens, Contact, For Reading Discomfort886.592521
HRCSterilizer, Soft-Lens, Thermal, Battery-Powered886.592821
HRDSterilizer, Soft-Lens, Thermal, Ac-Powered886.592821
LPNAccessories, Soft Lens Products886.59282122
LRXCase, Contact Lens886.5928282
LYLAccessories, Solution, Ultrasonic Cleaners For Lenses886.5928222
NFJSystem, Image Management, Ophthalmic892.2050251
Innolitics

Panel 1

/
Sort by
Ready

Predicate graph will load when search results are available.

Embedding visualization will load when search results are available.

PDF viewer will load when search results are available.

Loading panels...

Select an item from the tree

Click any panel, subpart, regulation, product code, or device to see details here.

Section Matches

Results will appear here.

Product Code Matches

Results will appear here.

Special Control Matches

Results will appear here.

Loading collections...