HQE · Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Ophthalmic · 21 CFR 886.4150 · Class 2
Overview
| Product Code | HQE |
|---|---|
| Device Name | Instrument, Vitreous Aspiration And Cutting, Ac-Powered |
| Regulation | 21 CFR 886.4150 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.
Classification Rationale
Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Recent Cleared Devices (20 of 149)
Showing 20 most recent of 149 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K212763 | UniVit HE, UniVit UHS | Visioncare Devices, LLC | Aug 10, 2022 | SESE |
| K170183 | Cetus system, Cetus probe | A.R.C Laser GmbH | Sep 27, 2017 | SESE |
| K153168 | Bi-Blade Vitrectomy Cutter | Medical Instrument Development Laboratories | Apr 29, 2016 | SESE |
| K141065 | CONSTELLATION VISION SYSTEM | Alcon Research, Ltd. | Aug 22, 2014 | SESE |
| K121675 | VERSAVIT | Synergetics, Inc. | Jun 21, 2012 | SESE |
| K120170 | PROCARE PLUS VITRECTOMY SYSTEM | Visioncare Devices, Inc. | May 30, 2012 | SESE |
| K102222 | ULTIMATE VIT ENHAMCER (UVE) | Medical Instrument Development Laboratories, Inc. | Apr 8, 2011 | SESE |
| K033390 | COLIBRI DISPOSABLE VITRECTOMY CUTTER | Microworld Medical Instruments, Inc. | Nov 4, 2003 | SESE |
| K030948 | VMATE MODEL VMM1000 | Howard Instruments, Inc. | Jun 17, 2003 | SESE |
| K023939 | VELOCITY ADVANTAGE | Visioncare Devices, Inc. | Apr 17, 2003 | SESE |
| K020911 | MID LABS AUTONOMOUS VIT ENHANCER (AVE) | Medical Instrument Development Laboratories, Inc. | Apr 29, 2002 | SESE |
| K010082 | D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM | Dutch Ophthalmic USA, Inc. | Mar 12, 2001 | SESE |
| K992943 | VIT ENHANCER | Medical Instrument Development Laboratories, Inc. | Dec 10, 1999 | SESE |
| K990292 | I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN | Ophthalmic Consultants, Inc. | Nov 19, 1999 | SESE |
| K983797 | D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM | Dutch Ophthalmic USA, Inc. | Mar 3, 1999 | SESE |
| K980400 | PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10 | Peregrine Surgical , Ltd. | Apr 30, 1998 | SESE |
| K980399 | PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20 | Peregrine Surgical , Ltd. | Apr 30, 1998 | SESE |
| K980488 | STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM | Storz Instrument Co. | Mar 23, 1998 | SESE |
| K970670 | REUSABLE VITRECTOMY PROBE | Altex Vision | May 6, 1997 | SESE |
| K970673 | DISPOSABLE VITRECTOMY PROBE | Altex Vision | May 5, 1997 | SESE |
Top Applicants
- Storz Instrument Co. — 16 clearances
- Medical Instrument Development Laboratories, Inc. — 13 clearances
- CooperVision, Inc. — 7 clearances
- Site Microsurgical Systems, Inc. — 7 clearances
- Optical Micro Systems, Inc. — 6 clearances
