Pro-Vit
FDA 510(k) K950799 · M. Imonti and Associates Inc.,
510(k) numberK950799
Submission
- Device name
- Pro-Vit
- Applicant
- M. Imonti and Associates Inc.,
San Juan Capistrano, CA, US - Received
- February 21, 1995
- Decision date
- April 28, 1995
- 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
Other 510(k)s with product code HQE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K023939 | Velocity AdvantageHQE · Traditional | Visioncare Devices, Inc. | 04/17/2003SE |
More from Visioncare Devices, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K950800 | Pro-Pak for Oms DiplomateHQC · Traditional | 05/22/1995SE |
| K933627 | Phacofragmentor TipHQC · Traditional | 01/25/1994SE |
| K933503 | Pro-Phaco HandpieceHQC · Traditional | 01/06/1994SE |
| K924551 | Endo Trachea Tube FixationCBH · Traditional | 12/08/1992SE |
| K905766 | Drainage Tube Restraint/Wound CoverGBX · Traditional | 03/06/1991SE |
Questions and answers
When was Pro-Vit cleared by the FDA?
Pro-Vit (K950799) received a 510(k) decision of Substantially Equivalent on April 28, 1995, 66 days after the submission was received.
What is the product code of K950799?
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.