Product code MPA
- Device name
- Endoilluminator
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253468 | Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A) | Nova Eye, Inc. | 2026-08-10 |
| K242184 | Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); | Alcon Laboratories, Inc. | 2024-12-04 |
| K233653 | Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) | Peregrine Surgical, LLC | 2024-08-05 |
| K221872 | ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System | Nova Eye Inc. (Business Name Nova Eye Medical) | 2023-03-30 |
| K202670 | Nam illumination probe with chopper | Oculight , Ltd. | 2021-08-20 |
| K151604 | 23ga Chandelier Illuminator, 25ga Chandelier Illuminator | Peregrine Surgical , Ltd. | 2015-09-11 |
| K143123 | Synergetics PHOTON EX | Synergetics | 2015-02-24 |
| K080067 | ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER | Iscience Interventional | 2008-07-18 |
| K062895 | XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII | Dutch Ophthalmic Research Center International BV | 2006-10-13 |
| K062259 | ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100 | Iscience Surgical | 2006-08-15 |
| K041108 | ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA | Iscience Surgical Corporation | 2004-06-22 |
| K032598 | SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE | Synergetics, Inc. | 2003-11-24 |
| K000252 | INSIGHT 4000 ENDOSCOPE | Insight Instruments Mfg., Inc. | 2000-10-17 |
| K000416 | TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001 | Retinalabs.Com | 2000-05-08 |
| K980797 | PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR | Peregrine Surgical , Ltd. | 1998-05-19 |
| K980530 | PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.13 | Peregrine Surgical , Ltd. | 1998-05-12 |
| K980025 | PEREGRINE TAPERED DIFFUSION PROBE | Peregrine Surgical , Ltd. | 1998-03-31 |
| K980027 | PEREGRINE SHIELDED DIFFUSION PROBE | Peregrine Surgical , Ltd. | 1998-03-31 |
| K973229 | D.O.R.C. HEXON ILLUMINATION SYSTEM | Dutch Ophthalmic USA, Inc. | 1997-11-25 |
| K973293 | SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR | Vaughan Weeks | 1997-11-18 |
| K973290 | SYNTEC TRUE LIGHT ENDOILLUMIINATOR WITH PICK | Vaughan Weeks | 1997-11-14 |
| K973757 | D.O.R.C. SOLUX LIGHT SOURCE | Dutch Ophthalmic USA, Inc. | 1997-11-07 |
| K971679 | I-SCOPE OPHTHALMIC ENDOSCOPE | Ophthalmic Technologies, Inc. | 1997-06-25 |
| K970882 | ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.) | American Medical Devices, Inc. | 1997-06-24 |
| K964005 | SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE | Synergetics, Inc. | 1997-06-09 |
| K970875 | ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.) | American Medical Devices, Inc. | 1997-05-20 |
| K964405 | MBI ILLUMINATED RETINAL PICK | M.B. Industries, Inc. | 1997-05-13 |
| K964553 | MBI CO-AXIAL ILLUMINATED RETINAL PICK | M.B. Industries, Inc. | 1997-05-13 |
| K970878 | ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT | American Medical Devices, Inc. | 1997-05-06 |
| K971338 | SYNTEC, INC. DISPOSABLE BARE END FIBER | Syntec, Inc. | 1997-05-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840096215304 | XLEND23MULTIFLEX | KATALYST SURGICAL LLC | 2025-06-24 |
| 08717872035499 | TotalView Endoillumination Probe, with 2 exchangeable tips.(23 gauge / 0.6 mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2025-04-01 |
| 08717872035512 | Disposable Eckardt Twinlight Chandelier. (27 gauge / 0.4mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2025-03-31 |
| 08717872035406 | Endoillumination Probe, including illuminated scleral depressor.(20 gauge / 0.9 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2025-03-31 |
| 08717872035420 | 23 GA./0.6mm Shielded TotalView Endo. Probe, including ill. scleral depressor | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2025-03-31 |
| 08717872035444 | Shielded TotalView Endoillumination Probe, including illuminated scleral depress | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2025-03-31 |
| 08717872035451 | TotalView Endoillumination Probe, including illuminated scleral depressor.(23 ga | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2025-03-31 |
| 08717872035468 | TotalView Endoillumination Probe, including illuminated scleral depressor.(25 ga | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2025-03-31 |
| 08717872035475 | Endoillumination Probe, including illuminated scleral depressor.(25 gauge / 0.5 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2025-03-31 |
| 08717872035482 | Endoillumination Probe, including illuminated scleral depressor.(23 gauge / 0.6 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2025-03-31 |
| 08717872035505 | TotalView Endoillumination Probe, including illuminated scleral depressor.(20 ga | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2025-03-31 |
| 08717872009520 | Disposable Eckardt Twinlight Chandelier. (27 gauge / 0.4mm) | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2022-10-04 |
| 10840096213956 | 25ga Illuminated MultiFlex™ Laser Probe, DORC Connector | KATALYST SURGICAL LLC | 2021-01-07 |
| 00840096208313 | Short 19ga Needle Illumination Adapter | KATALYST SURGICAL LLC | 2020-06-10 |
| 00840096208306 | DORC Illumination Adapter | KATALYST SURGICAL LLC | 2020-06-10 |
| 00840096208290 | Stellaris Illumination Adapter | KATALYST SURGICAL LLC | 2020-06-10 |
| 00840096208283 | Constellation Illumination Adapter | KATALYST SURGICAL LLC | 2020-06-10 |
| 00840096208276 | Revolver Universal Connector | KATALYST SURGICAL LLC | 2020-06-08 |
| 10817489027759 | 23ga Illuminated MultiFlex™ Inverted Extendable Laser Probe, Iridex Connector | KATALYST SURGICAL LLC | 2019-04-03 |
| 10817489027773 | 27ga Stiff Illuminated MultiFlex™ Inverted Extendable Laser Probe, Iridex Connec | KATALYST SURGICAL LLC | 2019-04-03 |
| 10817489027766 | 25ga Stiff Illuminated MultiFlex™ Inverted Extendable Laser Probe, Iridex Connec | KATALYST SURGICAL LLC | 2019-04-03 |
| 10817489027742 | 27ga Stiff Illuminated MultiFlex™ Inverted Laser Probe, Iridex Connector | KATALYST SURGICAL LLC | 2019-04-03 |
| 10817489027735 | 25ga Stiff Illuminated MultiFlex™ Inverted Laser Probe, Iridex Connector | KATALYST SURGICAL LLC | 2019-04-03 |
| 10817489027728 | 23ga Illuminated MultiFlex™ Inverted Laser Probe, Iridex Connector | KATALYST SURGICAL LLC | 2019-04-03 |
| 10817489027711 | 27ga Stiff Illuminated MultiFlex™ Extendable Laser Probe, Iridex Connector | KATALYST SURGICAL LLC | 2019-04-03 |
| 10817489027704 | 25ga Stiff Illuminated MultiFlex™ Extendable Laser Probe, Iridex Connector | KATALYST SURGICAL LLC | 2019-04-03 |
| 10817489027698 | 23ga Illuminated MultiFlex™ Extendable Laser Probe, Iridex Connector | KATALYST SURGICAL LLC | 2019-04-03 |
| 10817489027681 | 27ga Stiff Illuminated MultiFlex™ Laser Probe, Iridex Connector | KATALYST SURGICAL LLC | 2019-04-03 |
| 10817489027674 | 25ga Stiff Illuminated MultiFlex™ Laser Probe, Iridex Connector | KATALYST SURGICAL LLC | 2019-04-03 |
| 10817489027391 | 23ga MultiFlex Laser Probe, Iridex Compatible | KATALYST SURGICAL LLC | 2018-11-26 |