Velocity Advantage
FDA 510(k) K023939 · Visioncare Devices, Inc.
510(k) numberK023939
Submission
- Device name
- Velocity Advantage
- Applicant
- Visioncare Devices, Inc.
Redding, CA, US - Received
- November 26, 2002
- Decision date
- April 17, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4150
- Specialty
- Ophthalmic
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|---|---|---|---|
| K212763 | UniVit HE, UniVit UHSHQE · Traditional | Visioncare Devices, LLC | 08/10/2022SE |
| K170183 | Cetus system, Cetus probeHQE · Traditional | A.R.C Laser GmbH | 09/27/2017SE |
| K153168 | Bi-Blade Vitrectomy CutterHQE · Special | Medical Instrument Development Laboratories | 04/29/2016SE |
| K141065 | Constellation Vision SystemHQE · Traditional | Alcon Research, Ltd. | 08/22/2014SE |
| K121675 | VersavitHQE · Traditional | Synergetics, Inc. | 06/21/2012SE |
| K120170 | Procare Plus Vitrectomy SystemHQE · Traditional | Visioncare Devices, Inc. | 05/30/2012SE |
| K102222 | Ultimate Vit Enhamcer (Uve)HQE · Traditional | Medical Instrument Development Laboratories, Inc. | 04/08/2011SE |
| K033390 | Colibri Disposable Vitrectomy CutterHQE · Traditional | Microworld Medical Instruments, Inc. | 11/04/2003SE |
| K030948 | Vmate Model VMM1000HQE · Traditional | Howard Instruments, Inc. | 06/17/2003SE |
| K020911 | Mid Labs Autonomous Vit Enhancer (Ave)HQE · Traditional | Medical Instrument Development Laboratories, Inc. | 04/29/2002SE |
More from Medical Instrument Development Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K212763 | UniVit HE, UniVit UHSHQE · Traditional | 08/10/2022SE |
| K120170 | Procare Plus Vitrectomy SystemHQE · Traditional | 05/30/2012SE |
| K971064 | Bayers Bimanual I/A HandpiecesHQC · Traditional | 06/09/1997SE |
| K940746 | Vit Cutter Model 94HQE · Traditional | 06/06/1994SE |
| K904909 | I/A Vitrophage Model Ypr 2001HQE · Traditional | 01/28/1991SE |
Questions and answers
When was Velocity Advantage cleared by the FDA?
Velocity Advantage (K023939) received a 510(k) decision of Substantially Equivalent on April 17, 2003, 142 days after the submission was received.
What is the product code of K023939?
The FDA product code is HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4150.