Clarus (700)
FDA 510(k) K243878 · Carl Zeiss Meditec, Inc.
510(k) numberK243878
Submission
- Device name
- Clarus (700)
- Applicant
- Carl Zeiss Meditec, Inc.
Dublin, CA, US - Received
- December 18, 2024
- Decision date
- April 17, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QER – Camera, Ophthalmic, Slit-Scanning
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1120
- Specialty
- Ophthalmic
An ophthalmic slit-scanning camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
Other 510(k)s with product code QER
More from Carl Zeiss Meditec, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260694 | Zeiss Clinic 360NFJ · Traditional | 07/17/2026SE |
| K241174 | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical…JAD · Traditional | 01/10/2025SE |
| K233911 | VISULAS combiHQF · Traditional | 09/06/2024SE |
| K240215 | Blue 400; Blue 400 SQFX · Traditional | 06/28/2024SE |
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| K233421 | Rescan 700OBO · Traditional | 03/08/2024SE |
| K232944 | CALLISTO eyeNFJ · Special | 12/21/2023SE |
| K232051 | VISULAS greenHQF · Traditional | 10/24/2023SE |
| K230350 | VISULAS yagHQF · Traditional | 09/22/2023SE |
| K232159 | QEVO SystemGWG · Special | 09/21/2023SE |
Questions and answers
When was Clarus (700) cleared by the FDA?
Clarus (700) (K243878) received a 510(k) decision of Substantially Equivalent on April 17, 2025, 120 days after the submission was received.
What is the product code of K243878?
The FDA product code is QER – Camera, Ophthalmic, Slit-Scanning, a Class II (moderate risk) device regulated under 21 CFR 886.1120.