Ultimate Vit Enhancer™
The Ultimate Vit Enhancer is a standalone control console used with a standard ophthalmic surgical system to remove vitreous and other intraocular tissue. It operates only with MID Labs…
The Ultimate Vit Enhancer is a standalone control console used with a standard ophthalmic surgical system to remove vitreous and other intraocular tissue. It operates only with MID Labs vitreous cutters labeled for use with the enhancer. The host is typically phacoemulsification or vitreoretinal surgical equipment.
The console uses an external pneumatic energy input and an electronic pressure regulator to control that energy. A solenoid output valve drives the guillotine-type vitreous cutter at a user-selected frequency related to the host system’s frequency.
Listed Item
Ultimate Vit Enhancer™, 8000cpm capable
Controls
Frequency settings and their display are located on the front panel. The console is intended for prescription use with its compatible cutter and host equipment.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| ABA Medical Technology Co Ltd | Guang Dong | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Medical Instrument Development Laboratories, Inc., United States |
|---|---|
| FDA product code | HQE |
| Device type | Instrument, Vitreous Aspiration And Cutting, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.4150 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K102222 |
| Record published | 2016-09-23 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -40 to 70 °C; Storage environment humidity 10 to 100 % RH; Storage environment atmospheric pressure 20 to 110 KiloPascal; Handling environment temperature -40 to 70 °C; Handling environment humidity 10 to 100 % RH; Handling environment atmospheric pressure 20 to 110 KiloPascal |
| Sizes | Depth 11.25 in; width 6.75 in; height 11 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6400 | Depth 11.25 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bausch + Lomb | Bausch & Lomb Incorporated | 108 |
| Unity | Alcon Laboratories, Inc. | 47 |
| Synergetics | Synergetics USA, Inc. | 44 |
| Bi-Blade® | Medical Instrument Development Laboratories, Inc. | 28 |
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | Medical Instrument Development Laboratories, Inc. | 21 |
| Alcon | Alcon Laboratories, Inc. | 14 |
| Constellation | Alcon Laboratories, Inc. | 9 |
| Stellaris | Bausch & Lomb Incorporated | 6 |
| EVA Nexus™ Posterior 25G TDC Pack | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 4 |
| EVA Nexus™ Posterior 23G TDC Pack | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 4 |
| EVA Nexus™ Posterior 27G TDC Pack | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 4 |
| Engauge, Vektor | Alcon Laboratories, Inc. | 3 |
Showing 12 of 65. All products under Instrument, Vitreous Aspiration And Cutting, Ac-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K153168 | 2016-04-29 |
| K102222 | 2011-04-08 |
| K020911 | 2002-04-29 |
| K992943 | 1999-12-10 |
| K934600 | 1994-07-27 |
| K932669 | 1994-06-03 |
| K924222 | 1993-01-27 |
| K851610 | 1985-07-22 |
| K850857 | 1985-03-29 |
| K842793 | 1984-12-19 |
| K843391 | 1984-12-19 |
| K842471 | 1984-11-21 |
| K831584 | 1983-08-12 |
| K820026 | 1982-02-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.