Home / 510(k) Clearances / K191194

510(k) K191194

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

K191194 is an FDA 510(k) premarket notification submitted by Carl Zeiss Meditec, Inc. for the device "CLARUS". The FDA issued a decision of Substantially Equivalent on June 25, 2019. The device falls under product code QER (Camera, Ophthalmic, Slit-Scanning), a Class II device regulated under 21 CFR 886.1120. Carl Zeiss Meditec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2019
Date Received
May 3, 2019
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.

  • K260694 — ZEISS CLINIC 360 (July 17, 2026)
  • K243878 — CLARUS (700) (April 17, 2025)
  • K241174 — INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spheric (January 10, 2025)
  • 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)

Other clearances for product code QER

  • K243878 — CLARUS (700) (April 17, 2025)
  • K181444 — CLARUS (January 10, 2019)

FDA data resources