510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K023045Substantially Equivalent

Microrupter V

Meridian AG, Thun, Bern, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K023045 is the FDA 510(k) clearance record for MICRORUPTER V, a class II device, cleared for Meridian AG on under FDA product code LXS (Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla). FDA records list 13 510(k) clearances for Meridian AG, from to . As of , FDA records show no recalls naming K023045.

Clearance record

Decision date
Received
(14 days to decision)
Product code
LXS Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
Regulation
21 CFR 886.4392
Device class
Class II
Review panel
Ophthalmic
Applicant
Meridian AG Bierigutstrasse 7, Thun, Bern, CH
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code LXS

Trailing 12 months

FDA records hold no clearances under product code LXS in the trailing twelve months.

FDA records show no clearances under product code LXS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LXS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260