Part 886 Subpart E—Surgical Devices
FDA submissions for Part 886 Subpart E—Surgical Devices in the Ophthalmic (OP) review panel, including product codes, regulations, and recent device decisions.
Section range: §§ 886.4070–886.4855
CFR Part: 886
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| HLD | Engine, Trephine, Accessories, Gas-Powered | 886.4070 | 1 | 0 |
| HOG | Burr, Corneal, Battery-Powered | 886.4070 | 1 | 5 |
| HQS | Burr, Corneal, Ac-Powered | 886.4070 | 1 | 1 |
| HRF | Engine, Trephine, Accessories, Battery-Powered | 886.4070 | 1 | 0 |
| HRG | Engine, Trephine, Accessories, Ac-Powered | 886.4070 | 1 | 6 |
| OHW | Burr, Corneal, Battery Powered, Rust Ring Removal | 886.4070 | 1 | 0 |
| OHX | Burr, Corneal, Ac-Powered, Rust Ring Removal | 886.4070 | 1 | 0 |
| HQQ | Apparatus, Cautery, Radiofrequency, Battery-Powered | 886.4100 | 2 | 3 |
| HQR | Apparatus, Cautery, Radiofrequency, Ac-Powered | 886.4100 | 2 | 11 |
| NCR | Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered | 886.4100 | 2 | 3 |
| PUL | Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered | 886.4100 | 2 | 4 |
| HQO | Unit, Cautery, Thermal, Ac-Powered | 886.4115 | 2 | 12 |
| HQP | Unit, Cautery, Thermal, Battery-Powered | 886.4115 | 2 | 24 |
| HKP | Instrument, Vitreous Aspiration And Cutting, Battery-Powered | 886.4150 | 2 | 16 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 886.4150 | 2 | 149 |
| MLZ | Vitrectomy, Instrument Cutter | 886.4150 | 2 | 4 |
| MMC | Dilator, Expansive Iris (Accessory) | 886.4150 | 2 | 0 |
| MSR | Tubing, Replacement, Phacofragmentation Unit | 886.4150 | 2 | 5 |
| QDY | Vitrectomy Kit | 886.4150 | 2 | 0 |
| LXP | Plug, Scleral | 886.4155 | 2 | 10 |
| HPS | Unit, Cryophthalmic | 886.4170 | 2 | 11 |
| HQA | Unit, Cryotherapy, Ophthalmic | 886.4170 | 2 | 4 |
| HRN | Unit, Cryophthalmic, Ac-Powered | 886.4170 | 2 | 10 |
| HMS | Drum, Eye Knife Test | 886.4230 | 1 | 1 |
| HPY | Unit, Electrolysis, Battery-Powered, Ophthalmic | 886.4250 | 1 | 1 |
| HRO | Unit, Electrolysis, Ac-Powered, Ophthalmic | 886.4250 | 2 | 0 |
| LPO | Gases Used Within Eye To Place Pressure On Detached Retina | 886.4270 | 3 | 4 |
| LWL | Fluid, Intraocular | 886.4275 | 3 | 5 |
| LZP | Aid, Surgical, Viscoelastic | 886.4275 | 3 | 13 |
| NVB | Intraocular, Pressure Measuring Device | 886.4280 | 3 | 0 |
| KYB | Lens, Guide, Intraocular | 886.4300 | 1 | 39 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | 886.4300 | 1 | 62 |
| NCE | Injector, Capsular Tension Ring | 886.4300 | 1 | 3 |
| OTZ | Graft Insertion Instrument For Endothelial Keratoplasty | 886.4300 | 1 | 5 |
| QQQ | Guide And Positioner, Ophthalmic Drug Delivery Device | 886.4300 | 1 | 0 |
| QCW | Corneal Storage Media With Preservatives Including Anti-Fungal | 886.4320 | 2 | 1 |
| FCT | Headlight, Fiberoptic Focusing | 886.4335 | 2 | 6 |
| FSR | Light, Headband, Surgical | 886.4335 | 2 | 4 |
| HPP | Headlamp, Operating, Battery-Operated | 886.4335 | 1 | 0 |
| HPQ | Headlamp, Operating, Ac-Powered | 886.4335 | 2 | 5 |
| HMX | Cannula, Ophthalmic | 886.4350 | 1 | 77 |
| HMZ | Trabeculotome | 886.4350 | 1 | 0 |
| HNA | Spud, Ophthalmic | 886.4350 | 1 | 2 |
| HNB | Spoon, Ophthalmic | 886.4350 | 1 | 0 |
| HNC | Specula, Ophthalmic | 886.4350 | 1 | 11 |
| HND | Spatula, Ophthalmic | 886.4350 | 1 | 6 |
| HNE | Snare, Enucleating | 886.4350 | 1 | 0 |
| HNF | Scissors, Ophthalmic | 886.4350 | 1 | 15 |
| HNG | Rongeur, Lachrymal Sac | 886.4350 | 1 | 0 |
| HNH | Ring, Ophthalmic (Flieringa) | 886.4350 | 1 | 7 |
| HNI | Retractor, Ophthalmic | 886.4350 | 1 | 2 |
| HNJ | Punch, Corneo-Scleral | 886.4350 | 1 | 3 |
| HNK | Probe, Trabeculotomy | 886.4350 | 1 | 0 |
| HNL | Probe, Lachrymal | 886.4350 | 1 | 10 |
| HNM | Needle, Ophthalmic Suturing | 886.4350 | 1 | 2 |
| HNN | Knife, Ophthalmic | 886.4350 | 1 | 54 |
| HNP | Introducer, Sphere | 886.4350 | 1 | 0 |
| HNQ | Hook, Ophthalmic | 886.4350 | 1 | 10 |
| HNR | Forceps, Ophthalmic | 886.4350 | 1 | 44 |
| HNS | Expressor | 886.4350 | 1 | 0 |
| HNT | Erisophake | 886.4350 | 1 | 0 |
| HNW | Dilator, Lachrymal | 886.4350 | 1 | 3 |
| HNX | Depressor, Orbital | 886.4350 | 1 | 2 |
| HNY | Cystotome | 886.4350 | 1 | 20 |
| HNZ | Curette, Ophthalmic | 886.4350 | 1 | 2 |
| HOA | Compressor, Orbital | 886.4350 | 1 | 0 |
| HOB | Clamp, Muscle, Ophthalmic | 886.4350 | 1 | 3 |
| HOC | Clip, Iris Retractor | 886.4350 | 1 | 2 |
| HOD | Clamp, Eyelid, Ophthalmic | 886.4350 | 1 | 3 |
| HOE | Caliper, Ophthalmic | 886.4350 | 1 | 7 |
| HOF | Burr, Corneal, Manual | 886.4350 | 1 | 1 |
| HRH | Trephine, Manual, Ophthalmic | 886.4350 | 1 | 12 |
| MXY | Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | 886.4350 | 1 | 0 |
| NGY | Cannula, Trocar, Ophthalmic | 886.4350 | 1 | 1 |
| NLA | Knife, Ophthalmic, Reprocessed | 886.4350 | 1 | 0 |
| PZG | Surgical Eye Tray | 886.4350 | 1 | 0 |
| QDV | Iol Tray | 886.4350 | 1 | 0 |
| QGJ | Corneal Inlay Inserter Handle | 886.4355 | 1 | 0 |
| KYG | Device, Irrigation, Ocular Surgery | 886.4360 | 1 | 40 |
| HMY | Keratome, Battery-Powered | 886.4370 | 1 | 12 |
| HNO | Keratome, Ac-Powered | 886.4370 | 1 | 83 |
| MYD | Keratome, Water Jet | 886.4370 | 1 | 1 |
| NKY | Blade, Keratome, Reprocessed | 886.4370 | 1 | 0 |
| HQF | Laser, Ophthalmic | 886.4390 | 2 | 180 |
| LQJ | Lens, Surgical, Laser, Accesssory, Ophthalmic Laser | 886.4390 | 2 | 13 |
| OOE | Ophthalmic Femtosecond Laser | 886.4390 | 2 | 47 |
| LXS | Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla | 886.4392 | 2 | 7 |
| HPM | Locator, Metal, Electronic | 886.4400 | 2 | 4 |
| HPO | Magnet, Ac-Powered | 886.4440 | 2 | 3 |
| FTZ | Locator, Magnetic | 886.4445 | 1 | 2 |
| HPN | Magnet, Permanent | 886.4445 | 1 | 5 |
| HMQ | Marker, Sclera | 886.4570 | 1 | 0 |
| HMR | Marker, Ocular | 886.4570 | 1 | 5 |
| HRP | Pen, Marking, Surgical | 886.4570 | 1 | 0 |
| LCC | Applicator, Ocular Pressure | 886.4610 | 2 | 6 |
| HQC | Unit, Phacofragmentation | 886.4670 | 2 | 315 |
| MUS | Fluidic, Phacoemulsification/Phacofragmentation | 886.4670 | 2 | 1 |
| MXO | Laser, System, Phacolysis | 886.4670 | 2 | 0 |
| NKX | Needle, Phacoemulsification, Reprocessed | 886.4670 | 2 | 5 |
| QDW | Phaco Kit | 886.4670 | 2 | 0 |
| HQB | Photocoagulator And Accessories | 886.4690 | 2 | 30 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | 886.4750 | 1 | 55 |
| MOE | Collagen Corneal Shield | 886.4750 | 1 | 19 |
| HOH | Spectacle, Operating (Loupe), Ophthalmic | 886.4770 | 1 | 3 |
| HOZ | Sponge, Ophthalmic | 886.4790 | 2 | 47 |
| OJK | Eye Tray | 886.4790 | 2 | 0 |
| HRJ | Table, Instrument, Powered, Ophthalmic | 886.4855 | 1 | 7 |
| HRK | Table, Instrument, Manual, Ophthalmic | 886.4855 | 1 | 2 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K252979 | Voyager DSLT (430840610) | Belkin Vision, Ltd. | Apr 7, 2026 |
| K252052 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) | Bausch and Lomb, Incorporated | Mar 25, 2026 |
| K251507 | INTEGRE LIO | Quantel Medical | Feb 6, 2026 |
| K250501 | System Sophi | This AG | Nov 14, 2025 |
| K251772 | Navilas Laser System 577sl (156691) | Od-Os GmbH | Oct 29, 2025 |
| K252682 | LenSx Laser System (8065000944) | Alcon Laboratories, Inc. | Sep 24, 2025 |
| K252540 | ACCUJECT Injector Set 2.1-1P (LP604590) | Medicel AG | Sep 16, 2025 |
| K243395 | MICOR 700 with Auto I/A | Carl Zeiss Meditec Cataract Technology, Inc. | Aug 8, 2025 |
| K243014 | EyeQ nanoECP | Eyeq, Inc. | Jun 18, 2025 |
| K242801 | MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185) | Carl Zeiss Meditec Cataract Technology, Inc. | Jun 11, 2025 |
| K243896 | LenSx Laser System (8065998162) | Alcon Laboratories, Inc. | Apr 28, 2025 |
| K240615 | Leos Laser and Endoscopy System | Beaver-Visitec International, Inc. | Apr 3, 2025 |
| K242397 | LYNX Photocoagulator | Norlase Aps | Oct 25, 2024 |
| K242389 | EyeGility Inserter for Preloaded enVista IOLs | Bausch & Lomb, Incorporated | Oct 10, 2024 |
| K233911 | VISULAS combi | Carl Zeiss Meditec, AG | Sep 6, 2024 |
| P230012 | UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy | Alcon Research, LLC | Aug 26, 2024 |
| K240169 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) | Bausch and Lomb, Incorporated | Jul 26, 2024 |
| P220030 | UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery | Alcon Research, LLC | Jul 2, 2024 |
| K233398 | Faros Surgical System | Oertli Instrumente AG | Jun 27, 2024 |
| K233876 | UNITY VCS (8065000296); UNITY CS (8065000297) | Alcon Laboratories, Inc. | Jun 21, 2024 |
| K232084 | Stellaris Elite vision enhancement system | Bausch and Lomb | Feb 26, 2024 |
| K232417 | MR Q; MR Q SUPINE; MR Q SLT | Meridian AG | Jan 25, 2024 |
| K233902 | Centurion Vision System (Active Sentry) (8065753057) | Alcon Laboratories, Inc. | Jan 10, 2024 |
| K230722 | Eagle device | Belkin Vision, Ltd. | Dec 8, 2023 |
| K232051 | VISULAS green | Carl Zeiss Meditec | Oct 24, 2023 |
| K230350 | VISULAS yag | Carl Zeiss Meditec, Inc. | Sep 22, 2023 |
| K231106 | Accuject Refra Injector AR2900 | Medicel AG | Sep 19, 2023 |
| K231011 | Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse | Meridian AG | Sep 12, 2023 |
| K231838 | RxSight® Insertion Device (63002) | Rxsight, Inc. | Aug 15, 2023 |
| K230858 | QUATERA 700 | Carl Zeiss Meditec, AG | Jul 31, 2023 |
| K231466 | RxSight Insertion Device | Rxsight, Inc. | Jun 12, 2023 |
| K223566 | ELITA Femtosecond Laser System, ELITA Patient Interface | Johnson & Johnson Surgical Vision, Inc. | Apr 14, 2023 |
| K223838 | Catalys Precision Laser System | Amo Manufacturing USA, LLC | Apr 12, 2023 |
| K223763 | ZeptoLink IOL Positioning System | Centricity Vision, Inc. | Apr 11, 2023 |
| K230228 | Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) | Iridex Corporation | Feb 23, 2023 |
| P220009 | StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD) | Bausch Health Companies, Inc. | Feb 22, 2023 |
| K220974 | R:GEN | Lutronic Vision, Inc. | Dec 27, 2022 |
| K223132 | Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) | Iridex Corporation | Nov 9, 2022 |
| K220263 | Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers | Vortex Surgical, Inc. | Nov 3, 2022 |
| K222395 | Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo | Ellex Medical Pty, Ltd. | Nov 2, 2022 |
| K222157 | ECHO Photocoagulator | Norlase | Oct 11, 2022 |
| K214028 | MICOR Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | Sep 9, 2022 |
| K222236 | miCOR System Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | Aug 24, 2022 |
| K212763 | UniVit HE, UniVit UHS | Visioncare Devices, LLC | Aug 10, 2022 |
| K220877 | Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems | Lumenis Be, Inc. | Jul 15, 2022 |
| K221188 | ZEPTO Precision Capsulotomy System | Centricity Vision, Inc. | Jun 23, 2022 |
| K213467 | EVA NEXUS Ophthalmic Surgical System | D.O.R.C. Dutch Ophthalmic Research Center (International) | Jun 14, 2022 |
| K220259 | ALLY Adaptive Cataract Treatment System | Lensar, Inc. | Jun 9, 2022 |
| K220516 | CATALYS Precision Laser system | Amo Manufacturing USA, LLC | May 17, 2022 |
| K220430 | Capsulo | Quantel Medical | May 12, 2022 |
| K220030 | Vista Ophthalmics Vitrectomy Probe | Vista Ophthalmics, LLC | May 4, 2022 |
| DEN200063 | Kerasave | Al.Chi.Mi.A. S.R.L | May 2, 2022 |
| K213559 | FEMTO LDV Z8 Femtosecond Surgical Laser | Sie Ag,Surgical Instrument Engineering | Apr 21, 2022 |
| K212241 | QUATERA 700 | Carl Zeiss Meditec, AG | Apr 19, 2022 |
| K213592 | Iridex 810 Laser | Iridex Corporation | Mar 23, 2022 |
| K203586 | EndoSerter-PL | Corneagen, Inc. | Feb 2, 2022 |
| K212630 | Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo | Ellex Medical Pty, Ltd. | Dec 16, 2021 |
| K210827 | ZEPTO Precision Capsulotomy System | Centricity Vision, Inc. | Dec 14, 2021 |
| K212039 | CLAREON MONARCH IV IOL Delivery System | Alcon Laboratories, Inc. | Aug 23, 2021 |
| K210701 | CATALYS Precision Laser System | Amo Manufacturing USA, LLC | Apr 7, 2021 |
| P200025 | ClearVisc Ophthalmic Viscosurgical Device (OVD) | Bausch Health | Mar 23, 2021 |
| K203060 | VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control | Johnson & Johnson Surgical Vision, Inc. | Mar 12, 2021 |
| K202038 | CryoTreQ | VitreQ BV | Dec 30, 2020 |
| K203130 | Ophthalmic Yag Laser System YC-200 | Nidek Co., Ltd. | Dec 7, 2020 |
| K202760 | Iridex 810 Laser | Iridex Corporation | Oct 21, 2020 |
| K200207 | xPORT S Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | Oct 15, 2020 |
| K200724 | VICTUS Femtosecond Laser Platform | Technolas Perfect Vision GmbH | Sep 1, 2020 |
| K201623 | LION Photocoagulator | Norlase Aps | Aug 11, 2020 |
| K201502 | Vitra 810 | Quantel Medical | Aug 6, 2020 |
| K200584 | xPORT 304 (miCOR) System Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | Jul 31, 2020 |
| K193376 | Visalis V500, Visalis S500 | Carl Zeiss Meditec, AG | Jun 15, 2020 |
| K200057 | bioli lOL Delivery System | Ast Products, Inc. | Jun 4, 2020 |
| K200911 | MIRA Adapter | Phakos | Jun 2, 2020 |
| K192418 | Phacoemulsification Needle (Tip) and Irrigation Sleeve | Raico, LLC | May 27, 2020 |
| K200056 | Catalys Precision Laser System | Amo Manufacturng USA, LLC | May 18, 2020 |
| K192926 | RxSight Insertion Device | Rxsight, Inc. | Jan 17, 2020 |
| K191846 | MAXReach Laser Probe | Vortex Surgical, Inc. | Dec 23, 2019 |
| K192045 | Ophthalmic Yag Laser System YC-200 | Nidek Co., Ltd. | Nov 15, 2019 |
| K191650 | LEGION System | Alcon Research, LLC | Nov 1, 2019 |
| K192005 | Bausch + Lomb PreVue Inserter for enVista Preloaded | Bausch & Lomb, Inc. | Oct 4, 2019 |
| K190875 | EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) | D.O.R.C. Dutch Ophthalmic Research Center (International) | Sep 25, 2019 |
| K191949 | UNFOLDER Vitan Inserter | Johnson & Johnson Surgical Vision, Inc. | Sep 13, 2019 |
| K191933 | COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal | Johnson & Johnson Surgical Vision, Inc. | Aug 16, 2019 |
| K191024 | xPORT Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | Aug 13, 2019 |
| K190448 | LightLas Pattern Scanning System - TruScan Pro | Light-Med(Usa), Inc. | May 24, 2019 |
| K190083 | Leaf Photocoagulator | Norlase Aps | May 3, 2019 |
| K182646 | Vitreq disposable laser probes, light fibers and Chandelier | VitreQ BV | May 1, 2019 |
| K182965 | BL-Cart IOL Delivery Cartridge | Ast Products, Inc. | Mar 29, 2019 |
| K181682 | VISULAS green | Carl Zeiss Meditec, AG | Mar 6, 2019 |
| K182795 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | Dec 21, 2018 |
| K182083 | Catalys Precision Laser System | Amo Manufacturing USA, LLC | Nov 9, 2018 |
| K181430 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | Aug 9, 2018 |
| K181401 | RxSight Insertion Device | Rxsight, Inc. | Jul 26, 2018 |
| K180402 | PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar | Topcon Medical Laser Systems, Inc. | May 25, 2018 |
| K173371 | VisuMax Femtosecond Laser | Carl Zeiss Meditec, Inc. | Apr 13, 2018 |
| K173660 | LenSx Laser System | Alcon Laboratories, Inc. | Mar 27, 2018 |
| K180195 | Frigitronics adapter | Phakos | Mar 16, 2018 |
| K173346 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | Mar 2, 2018 |
| K172228 | pioli IOL Delivery System | Ast Products, Inc. | Dec 15, 2017 |
| K173480 | Crystalsert Lens Delivery System | Bausch & Lomb, Inc. | Dec 11, 2017 |
