Versatome I
FDA 510(k) K820008 · Alphamedix, Inc.
510(k) numberK820008
Submission
- Device name
- Versatome I
- Applicant
- Alphamedix, Inc.
Mchenry, IL, US - Received
- January 4, 1982
- Decision date
- February 22, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K852706 | VersabladeHNN · Traditional | 11/04/1985SN |
| K852633 | VersabladeHNN · Traditional | 11/04/1985SN |
| K851272 | VersaphageHQE · Traditional | 07/05/1985SE |
| K830812 | Alphamedix I/A Hand-Piece, 500-001HQC · Traditional | 06/08/1983SE |
| K830703 | GlomarkFZZ · Traditional | 04/28/1983SE |
| K820363 | Disposable Surgical GarmentsFYA · Traditional | 03/08/1982SE |
Questions and answers
When was Versatome I cleared by the FDA?
Versatome I (K820008) received a 510(k) decision of Substantially Equivalent on February 22, 1982, 49 days after the submission was received.
What is the product code of K820008?
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.