510(k) K243878
- Device
- CLARUS (700)
- Applicant
- Carl Zeiss Meditec, Inc.
- 510(k) number
- K243878
- Product code
- QER
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-04-17
- Date received
- 2024-12-18
- Regulation
- 886.1120
- Classification name
- Camera, Ophthalmic, Slit-Scanning
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Tanesha Bland
- Address
- 5300 Central Pkwy. Dublin CA US 94568 94568
FDA Registration Numbers#
- 2918630
- 3003589956