Constellation Vision System
FDA 510(k) K141065 · Alcon Research, Ltd.
510(k) numberK141065
Submission
- Device name
- Constellation Vision System
- Applicant
- Alcon Research, Ltd.
Lake Forest, CA, US - Received
- April 24, 2014
- Decision date
- August 22, 2014
- 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
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 |
| 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 |
| 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 |
|---|---|---|
| K191650 | LEGION SystemHQC · Traditional | 11/01/2019SE |
| K161794 | CENTURION Vision System (Active SentryTM)HQC · Traditional | 04/14/2017SE |
| K170520 | HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy…MLZ · Special | 03/22/2017SE |
| K121031 | Wavelight FS200 Patient Interface 1505GEX · Abbreviated | 06/21/2012SE |
| K112977 | Monarch III Iol Delivery System, Monarch III C Cartridge, Monarch III Handpiece (H4)MSS · Abbreviated | 03/27/2012SE |
| K110951 | 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved…HQB · Traditional | 10/17/2011SE |
| K110166 | Clearcut S Safety KnifeHNN · Abbreviated | 05/20/2011SE |
| K102860 | Alcon Multi-Pirpose Disinfecting SolutionLPN · Traditional | 05/10/2011SE |
| K101006 | Wavelight FS200 Laser System Model: FS200GEX · Traditional | 10/21/2010SE |
| K093305 | Enhanced Ultra Vit ProbeMLZ · Traditional | 04/02/2010SE |
Questions and answers
When was Constellation Vision System cleared by the FDA?
Constellation Vision System (K141065) received a 510(k) decision of Substantially Equivalent on August 22, 2014, 120 days after the submission was received.
What is the product code of K141065?
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.