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510(k) K222933

MYAH by Visia Imaging S.R.L. — Product Code MXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2023
Date Received
September 26, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Analysis, Anterior Segment
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type

Other clearances by Visia Imaging S.R.L.

  • K211868 — MYAH (March 1, 2022)
  • K160327 — ALADDIN HW3.0 (October 5, 2016)
  • K131567 — ALADDIN (June 5, 2014)

Other clearances for product code MXK

  • K251848 — Pentacam® Cornea OCT (March 13, 2026)
  • K252348 — Tomey Optical Biometer OA-2000 (OA-2000) (December 18, 2025)
  • K223700 — BOSS™ (August 16, 2024)
  • K211868 — MYAH (March 1, 2022)
  • K202989 — Myopia Master (July 14, 2021)
  • K201724 — Pentacam AXL Wave (October 21, 2020)
  • K182659 — Galilei G6 Lens Professional (July 25, 2019)
  • K191051 — ARGOS (May 16, 2019)
  • K152311 — Pentacam AXL (January 20, 2016)
  • K150754 — ARGOS (October 2, 2015)