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510(k) K233911

VISULAS combi by Carl Zeiss Meditec, AG — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2024
Date Received
December 12, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ophthalmic
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
Submission Type

Other clearances by Carl Zeiss Meditec, AG

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  • 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)
  • K231676 — CALLISTO eye (August 28, 2023)

Other clearances for product code HQF

  • K251507 — INTEGRE LIO (February 6, 2026)
  • K251772 — Navilas Laser System 577sl (156691) (October 29, 2025)
  • K243014 — EyeQ nanoECP (June 18, 2025)
  • K240615 — Leos Laser and Endoscopy System (April 3, 2025)
  • K242397 — LYNX Photocoagulator (October 25, 2024)
  • K232417 — MR Q; MR Q SUPINE; MR Q SLT (January 25, 2024)
  • K230722 — Eagle device (December 8, 2023)
  • K232051 — VISULAS green (October 24, 2023)
  • K230350 — VISULAS yag (September 22, 2023)
  • K231011 — Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse (September 12, 2023)