Zeiss Confocal Laser Scanning Ophthalmoscope(Clso)
FDA 510(k) K912581 · Carl Zeiss, Inc.
510(k) numberK912581
Submission
- Device name
- Zeiss Confocal Laser Scanning Ophthalmoscope(Clso)
- Applicant
- Carl Zeiss, Inc.
Princeton, NJ, US - Received
- June 12, 1991
- Decision date
- December 23, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HLI – Ophthalmoscope, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1570
- Specialty
- Ophthalmic
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Questions and answers
When was Zeiss Confocal Laser Scanning Ophthalmoscope(Clso) cleared by the FDA?
Zeiss Confocal Laser Scanning Ophthalmoscope(Clso) (K912581) received a 510(k) decision of Substantially Equivalent on December 23, 1991, 194 days after the submission was received.
What is the product code of K912581?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.