Endoilluminator
FDA product code MPA · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
41510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Peregrine Surgical , Ltd. 6
- Gamp & Assoc. 5
- M.B. Industries, Inc. 3
- American Medical Devices, Inc. 3
- Synergetics Inc 3
- Iscience Surgical Corporation 2
- Dutch Ophthalmic USA, Inc. 2
- Vaughan Weeks 2
- Ophthalmic Technologies, Inc. 1
- Nova Eye, Inc. 1
- Oculight , Ltd. 1
- Iscience Interventional 1
- Dutch Ophthalmic Research Center International BV 1
- Insight Instruments Mfg., Inc. 1
- Retinalabs.Com 1
- Syntec, Inc. 1
- Vitrotec, Inc. 1
- Escalon Trek Medical 1
- Storz 1
- Infinitech, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253468 | Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A)MPA · Traditional | Nova Eye, Inc. | 08/10/2026SE |
| K242184 | Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator…MPA · Traditional | Alcon Laboratories, Inc. | 12/04/2024SE |
| K233653 | Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00)…MPA · Traditional | Peregrine Surgical, LLC | 08/05/2024SE |
| K221872 | ITrack Advance Canaloplasty Microcatheter with Advanced Delivery SystemMPA · Abbreviated | Nova Eye Inc. (Business Name Nova Eye Medical) | 03/30/2023SE |
| K202670 | Nam illumination probe with chopperMPA · Traditional | Oculight , Ltd. | 08/20/2021SE |
| K151604 | 23ga Chandelier Illuminator, 25ga Chandelier IlluminatorMPA · Traditional | Peregrine Surgical , Ltd. | 09/11/2015SE |
| K143123 | Synergetics PHOTON EXMPA · Traditional | Synergetics | 02/24/2015SE |
| K080067 | Iscience Interventional Ophthalmic MicrocatheterMPA · Traditional | Iscience Interventional | 07/18/2008SE |
| K062895 | Xenon Brightstar Illumination System, Model 1266.XIIIMPA · Special | Dutch Ophthalmic Research Center International BV | 10/13/2006SE |
| K062259 | Iscience Surgical Fiberoptic Illuminator, Model Fi - 100MPA · Traditional | Iscience Surgical | 08/15/2006SE |
| K041108 | Iscience Surgical Ophthalmic MicrocannulaMPA · Traditional | Iscience Surgical Corporation | 06/22/2004SE |
| K032598 | Synergetics Synerlight Fiber Optic LightsourceMPA · Traditional | Synergetics, Inc. | 11/24/2003SE |
| K000252 | Insight 4000 EndoscopeMPA · Traditional | Insight Instruments Mfg., Inc. | 10/17/2000SE |
| K000416 | Transpak (Vitreoretinal Infusion Pak), Models 90000, 90001MPA · Traditional | Retinalabs.Com | 05/08/2000SE |
| K980797 | Peregrine Fiber Optic Multi-Function ManipulatorMPA · Traditional | Peregrine Surgical , Ltd. | 05/19/1998SE |
| K980530 | Peregrine Fiber Optic Bipolar Straight Pick and Angled Pick, Models PD100.12 and PD100.13MPA · Traditional | Peregrine Surgical , Ltd. | 05/12/1998SE |
| K980027 | Peregrine Shielded Diffusion ProbeMPA · Traditional | Peregrine Surgical , Ltd. | 03/31/1998SE |
| K980025 | Peregrine Tapered Diffusion ProbeMPA · Traditional | Peregrine Surgical , Ltd. | 03/31/1998SE |
| K973229 | D.O.R.C. Hexon Illumination SystemMPA · Traditional | Dutch Ophthalmic USA, Inc. | 11/25/1997SE |
| K973293 | Syntec True Light End Irrigating EndoilluminatorMPA · Traditional | Vaughan Weeks | 11/18/1997SE |
| K973290 | Syntec True Light Endoillumiinator with PickMPA · Traditional | Vaughan Weeks | 11/14/1997SE |
| K973757 | D.O.R.C. Solux Light SourceMPA · Traditional | Dutch Ophthalmic USA, Inc. | 11/07/1997SE |
| K971679 | I-Scope Ophthalmic EndoscopeMPA · Traditional | Ophthalmic Technologies, Inc. | 06/25/1997SE |
| K970882 | Endolight End Irrigating Endo-Illuminator (20 Ga. and 19 Ga.)MPA · Traditional | American Medical Devices, Inc. | 06/24/1997SE |
| K964005 | Synergetics Synerlight Fiber Optic LightsourceMPA · Traditional | Synergetics, Inc. | 06/09/1997SE |
| K970875 | Endolight Fiberoptic Endo-Illuminator (20 Ga. & 19 Ga.)MPA · Traditional | American Medical Devices, Inc. | 05/20/1997SE |
| K964553 | Mbi Co-Axial Illuminated Retinal PickMPA · Traditional | M.B. Industries, Inc. | 05/13/1997SE |
| K964405 | Mbi Illuminated Retinal PickMPA · Traditional | M.B. Industries, Inc. | 05/13/1997SE |
| K971338 | Syntec, Inc. Disposable Bare End FiberMPA · Traditional | Syntec, Inc. | 05/06/1997SE |
| K970878 | Endolight Fiberoptic Regular Monofilament and Fine MonofilamentMPA · Traditional | American Medical Devices, Inc. | 05/06/1997SE |
| K964555 | Vitrotec True Light Endoilluminator (100-S)MPA · Traditional | Vitrotec, Inc. | 03/31/1997SE |
| K963417 | Vitlite (TR7700)MPA · Traditional | Escalon Trek Medical | 12/20/1996SE |
| K961036 | Mbi Fiberoptic Endo-IlluminatorMPA · Traditional | M.B. Industries, Inc. | 07/15/1996SE |
| K960007 | Storz MVS 1011A Disposable Fiberoptic EndoilluminatorMPA · Traditional | Storz | 03/26/1996SE |
| K952585 | Gamp & Associates Disposable End Irrigating EndoilluminatorMPA · Traditional | Gamp & Assoc. | 01/05/1996SE |
| K952581 | Gamp & Associates Disposable Fiberoptic ViscoinjectorMPA · Traditional | Gamp & Assoc. | 01/05/1996SE |
| K951627 | Infinitech High Intensity Xenon Light Source SystemMPA · Traditional | Infinitech, Inc. | 10/19/1995SE |
| K946136 | Infinitech Lighted Infusion CannulaMPA · Traditional | Surgical Technologies, Inc. | 10/02/1995SE |
| K952586 | Gamp & Associates Disposable Fiberoptic EndoilluminatorMPA · Traditional | Gamp & Assoc. | 09/01/1995SE |
| K952584 | Gamp & Associates Disposable Endoilluminator W/PickMPA · Traditional | Gamp & Assoc. | 09/01/1995SE |
| K952580 | Gamp & Associates Disposable Bare End FiberMPA · Traditional | Gamp & Assoc. | 09/01/1995SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0307-2026 Class II | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and…Due to incomplete seals in the pouch which provide the sterile barrier. | Alcon Research LLC | 08/05/2025Open, Classified |