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510(k) K181444

CLARUS by Carl Zeiss Meditec, Inc. — Product Code QER

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2019
Date Received
June 1, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Ophthalmic, Slit-Scanning
Device Class
Class II
Regulation Number
886.1120
Review Panel
OP
Submission Type

An ophthalmic slit-scanning camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

Other clearances by Carl Zeiss Meditec, Inc.

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  • K233911 — VISULAS combi (September 6, 2024)
  • K240215 — BLUE 400; BLUE 400 S (June 28, 2024)
  • K233933 — CIRRUS™ HD-OCT Model 6000 (May 17, 2024)
  • K233421 — RESCAN 700 (March 8, 2024)
  • K232944 — CALLISTO eye (December 21, 2023)
  • K232051 — VISULAS green (October 24, 2023)
  • K230350 — VISULAS yag (September 22, 2023)
  • K232159 — QEVO System (September 21, 2023)

Other clearances for product code QER

  • K243878 — CLARUS (700) (April 17, 2025)
  • K191194 — CLARUS (June 25, 2019)