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510(k) K232417

MR Q; MR Q SUPINE; MR Q SLT by Meridian AG — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2024
Date Received
August 11, 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 Meridian AG

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  • K113390 — LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500) (February 14, 2012)
  • K072823 — MERILAS 532A (December 14, 2007)
  • K023045 — MICRORUPTER V (September 26, 2002)

Other clearances for product code HQF

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  • K240615 — Leos Laser and Endoscopy System (April 3, 2025)
  • K242397 — LYNX Photocoagulator (October 25, 2024)
  • K233911 — VISULAS combi (September 6, 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)