Dicon Glaucoma Diag. Center 2000 Series
FDA 510(k) K832142 · CooperVision, Inc.
510(k) numberK832142
Submission
- Device name
- Dicon Glaucoma Diag. Center 2000 Series
- Applicant
- CooperVision, Inc.
Southampton, GB - Received
- July 5, 1983
- Decision date
- August 1, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HPT – Perimeter, Automatic, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1605
- Specialty
- Ophthalmic
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|---|---|---|---|
| K092187 | Maia, Model 1HPT · Traditional | Centervue S.P.A. | 05/27/2010SE |
| K093213 | Guided Progression Analysis on the Humphrey Field Analyzer II and II -I SeriesHPT · Traditional | Carl Zeiss Meditec, Inc. | 03/12/2010SE |
| K091579 | Foresee HomeHPT · Traditional | Notal Vision , Ltd. | 12/23/2009SE |
| K063310 | Truefield AnalyzerHPT · Traditional | Seeing Machines Limited | 08/02/2007SE |
| K050350 | The Notal Vision Preview Preferential Hyperacuity Perimeter (Preview PHP)HPT · Traditional | Notal Vision, Inc. | 04/29/2005SE |
| K023623 | Novavision, Model 2.0HPT · Traditional | Novavision, Inc. | 04/22/2003SE |
| K971156 | Kasha Visual Field SystemHPT · Traditional | Kasha Software, Inc. | 05/28/1997SE |
| K961090 | Automatic Visual Field Plotter AP-125HPT · Traditional | Kowa Optimed, Inc. | 06/17/1996SE |
| K954167 | Humphrey Field Analyzer (Hfa II)HPT · Traditional | Carl Zeiss, Inc. | 11/24/1995SE |
| K954037 | Field TrendHPT · Traditional | Synemed, Inc. | 11/17/1995SE |
More from Synemed, Inc.
| 510(k) | Device | Decision |
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| K220070 | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality…LPL · Special | 02/04/2022SE |
| K213164 | Avaira VitalityLPL · Special | 10/26/2021SE |
| K202756 | Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day…LPL · Special | 10/20/2020SE |
| K191763 | MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A)…LPL · Traditional | 03/23/2020SE |
| K190965 | MyDayLPL · Special | 04/29/2019SE |
| K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV…LPL · Traditional | 12/11/2018SE |
| K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact LensLPL · Traditional | 07/13/2016SE |
| K133627 | Avaira Spheric and Toric (Enfilcon a) Soft Contact LensLPL · Special | 12/23/2013SE |
| K131378 | Sus (Stenfilcon a) Contact LensLPL · Traditional | 08/30/2013SE |
Questions and answers
When was Dicon Glaucoma Diag. Center 2000 Series cleared by the FDA?
Dicon Glaucoma Diag. Center 2000 Series (K832142) received a 510(k) decision of Substantially Equivalent on August 1, 1983, 27 days after the submission was received.
What is the product code of K832142?
The FDA product code is HPT – Perimeter, Automatic, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.1605.