Kowa Genesis Hand-Held Fundus Camera
FDA 510(k) K954781 · Kowa Optimed, Inc.
510(k) numberK954781
Submission
- Device name
- Kowa Genesis Hand-Held Fundus Camera
- Applicant
- Kowa Optimed, Inc.
Washington, DC, US - Received
- October 17, 1995
- Decision date
- December 1, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HKI – Camera, Ophthalmic, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1120
- Specialty
- Ophthalmic
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|---|---|---|
| K013805 | Kowa Automated Tonometer KT-500HKX · Traditional | 10/11/2002SE |
| K961090 | Automatic Visual Field Plotter AP-125HPT · Traditional | 06/17/1996SE |
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| K955442 | Kowa SC-1200 Photo Slit Lamp SystemHKI · Traditional | 01/03/1996SE |
| K954780 | Kowa Professional Fundus Camera Models FX-500, FX-500S, FX-500CHKI · Traditional | 12/01/1995SE |
| K954782 | Kowa Portable Slit Lamp SL-14 & SL-14BHJO · Traditional | 11/24/1995SE |
| K913852 | Laser Flare MeterHJO · Traditional | 02/07/1992SE |
| K880920 | Laser Flare Cell Meter FC-1000HJO · Traditional | 09/27/1988SE |
| K881219 | Automatic Perimeter, AP-340HPT · Traditional | 05/03/1988SE |
Questions and answers
When was Kowa Genesis Hand-Held Fundus Camera cleared by the FDA?
Kowa Genesis Hand-Held Fundus Camera (K954781) received a 510(k) decision of Substantially Equivalent on December 1, 1995, 45 days after the submission was received.
What is the product code of K954781?
The FDA product code is HKI – Camera, Ophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1120.