Slit Lamps with SL Cam 5.0 Digital Imaging Solution
FDA 510(k) K133476 · Carl Zeiss Meditec, AG
510(k) numberK133476
Submission
- Device name
- Slit Lamps with SL Cam 5.0 Digital Imaging Solution
- Applicant
- Carl Zeiss Meditec, AG
Dublin, CA, US - Received
- November 12, 2013
- Decision date
- February 12, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HJO – Biomicroscope, Slit-Lamp, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1850
- Specialty
- Ophthalmic
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Questions and answers
When was Slit Lamps with SL Cam 5.0 Digital Imaging Solution cleared by the FDA?
Slit Lamps with SL Cam 5.0 Digital Imaging Solution (K133476) received a 510(k) decision of Substantially Equivalent on February 12, 2014, 92 days after the submission was received.
What is the product code of K133476?
The FDA product code is HJO – Biomicroscope, Slit-Lamp, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1850.