Product code MRH
- Device name
- Pump, Infusion, Ophthalmic
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5725
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243503 | VIA360™ Surgical System | New World Medical, Inc. | 2025-02-14 |
| K232214 | OMNI Surgical System | Sight Sciences, Inc. | 2023-08-25 |
| K213173 | TrabEx Pro | Microsurgical Technologies, Inc. | 2022-06-08 |
| K212797 | iPrime Viscodelivery System | Glaukos | 2022-01-06 |
| K211680 | Streamline Surgical System | New World Medical, Inc. | 2021-10-08 |
| K202678 | OMNI Surgical System | Sight Sciences, Inc. | 2021-03-01 |
| K201953 | OMNI PLUS Surgical System | Sight Sciences, Inc. | 2020-08-11 |
| K173332 | OMNI Surgical System | Sight Sciences, Inc. | 2017-12-21 |
| K171905 | VISCO 360 Viscosurgical System | Sight Sciences, Inc. | 2017-07-27 |
| K143205 | Viscoelastic Injector | Sight Sciences, Inc. | 2014-12-05 |
| K132494 | VISCOELASTIC INJECTOR | Sight Sciences, Inc. | 2013-10-22 |
| K050716 | ISCIENCE SURGICAL VISCOINJECTOR | Iscience Surgical Corporation | 2005-04-21 |
| K000420 | SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003 | Retinalabs.Com | 2000-05-08 |
| K993039 | VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700) | Bausch & Lomb, Inc. | 2000-01-07 |
| K981907 | V.F.I.-VISCOUS FLUID INFUSION TUBING SET | Peregrine Surgical , Ltd. | 1998-08-04 |
| K974253 | CPD COMMANDER | Scieran Technologies, Inc. | 1998-02-25 |
| K972664 | STORZ MILLENNIUM VISCOUS FLUID SYSTEM | Storz Instrument Co. | 1997-10-10 |
| K971067 | DIGI-INJECTOR | Medical Instrument Development Laboratories, Inc. | 1997-09-19 |
| K963434 | VISCOUS FLUID SYSTEM | Escalon Trek Medical | 1996-11-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00893872001653 | iTrack 250E | Nova Eye, Inc. | 2026-05-05 |
| 00858027006594 | OMNI Edge Surgical System | Sight Sciences, Inc. | 2025-03-06 |
| 00892064002362 | VIA360 Surgical System | NEW WORLD MEDICAL, INCORPORATED | 2025-02-18 |
| 00892064002102 | Streamline Surgical System | NEW WORLD MEDICAL, INCORPORATED | 2025-02-15 |
| 00892064002072 | Streamline Surgical System | NEW WORLD MEDICAL, INCORPORATED | 2023-11-01 |
| 00858027006433 | OMNI Surgical System | Sight Sciences, Inc. | 2023-10-17 |
| 00844685009381 | TrabEx Pro | MICROSURGICAL TECHNOLOGY, INC. | 2022-09-22 |
| 00858027006525 | OMNI Surgical System | Sight Sciences, Inc. | 2022-08-22 |
| 00853704002456 | iPRIME | GLAUKOS CORPORATION | 2022-05-13 |
| 00892064002010 | Streamline® Surgical System | NEW WORLD MEDICAL, INCORPORATED | 2021-11-01 |
| 00858027006358 | OMNI PLUS | Sight Sciences, Inc. | 2020-10-30 |
| 00858027006372 | OMNI(R) Surgical System (US) | Sight Sciences, Inc. | 2020-06-01 |
| 00858027006334 | OMNI Surgical System (US) | Sight Sciences, Inc. | 2019-10-25 |
| 00893872001585 | ViscoInjector | Nova Eye, Inc. | 2019-01-28 |
| 00858027006310 | OMNI Surgical System (US) | Sight Sciences, Inc. | 2018-03-16 |
| 00858027006013 | VISCO(TM)360 Viscosurgical System | Sight Sciences, Inc. | 2016-09-22 |
| 00893872001059 | iTrack 250A | Nova Eye, Inc. | 2016-09-15 |
| 00853480006242 | Viscous Fluid Pack | ESCALON MEDICAL CORP. | 2016-01-14 |
| 10853480006010 | Viscous Fluid Pack | ESCALON MEDICAL CORP. | 2016-01-14 |
| 10853480006249 | Viscous Fluid Pack | ESCALON MEDICAL CORP. | 2016-01-14 |
| 00853480006013 | Viscous Fluid Pack | ESCALON MEDICAL CORP. | 2016-01-14 |