Kowa Genesis-D Hand-Held Retinal Camera
FDA 510(k) K050271 · Kowa Co. , Ltd.
510(k) numberK050271
Submission
- Device name
- Kowa Genesis-D Hand-Held Retinal Camera
- Applicant
- Kowa Co. , Ltd.
Chuo-Ku, Tokyo, JP - Received
- February 4, 2005
- Decision date
- November 3, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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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Questions and answers
When was Kowa Genesis-D Hand-Held Retinal Camera cleared by the FDA?
Kowa Genesis-D Hand-Held Retinal Camera (K050271) received a 510(k) decision of Substantially Equivalent on November 3, 2005, 272 days after the submission was received.
What is the product code of K050271?
The FDA product code is HKI – Camera, Ophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1120.