Part 886 Subpart E—Surgical Devices

FDA submissions for Part 886 Subpart E—Surgical Devices in the Ophthalmic (OP) review panel, including product codes and regulations.

Section range: §§ 886.4070–886.4855

CFR Part: 886

Product Codes

Product CodeDevice NameRegulationClassDevices
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, Phacofragmentation886.46702316
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
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