D.O.R.C. Harmony Total TTC Vitrectomy System
FDA 510(k) K010082 · Dutch Ophthalmic USA, Inc.
510(k) numberK010082
Submission
- Device name
- D.O.R.C. Harmony Total TTC Vitrectomy System
- Applicant
- Dutch Ophthalmic USA, Inc.
Kingston, NH, US - Received
- January 10, 2001
- Decision date
- March 12, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K141065 | Constellation Vision SystemHQE · Traditional | Alcon Research, Ltd. | 08/22/2014SE |
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| 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.
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|---|---|---|
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| K983797 | D.O.R.C. Harmony Total Vitrectomy SystemHQE · Traditional | 03/03/1999SE |
| K980636 | Fiber Optic Endoillumination ProbeFFS · Traditional | 05/20/1998SE |
| K973229 | D.O.R.C. Hexon Illumination SystemMPA · Traditional | 11/25/1997SE |
| K973757 | D.O.R.C. Solux Light SourceMPA · Traditional | 11/07/1997SE |
| K962135 | D.O.R.C. Microdiathermy SystemHQO · Traditional | 08/29/1996SE |
| K954842 | D.O.R.C. Vfi/Vfe SystemKYG · Traditional | 04/15/1996SE |
| K940373 | Ophthalmic Cryo UnitHPS · Traditional | 07/18/1994SE |
| K902491 | Eckhardt Temporary KeratoprosthesisMLP · Traditional | 06/26/1990SE |
Questions and answers
When was D.O.R.C. Harmony Total TTC Vitrectomy System cleared by the FDA?
D.O.R.C. Harmony Total TTC Vitrectomy System (K010082) received a 510(k) decision of Substantially Equivalent on March 12, 2001, 61 days after the submission was received.
What is the product code of K010082?
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.