510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895864Substantially Equivalent

Microruptor III Syst, Q-Switched Nd:yag Laser Comp

Lasag AG, Eden Prairie MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895864 is the FDA 510(k) clearance record for MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP, a class II device, cleared for Lasag AG on under FDA product code LXS (Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla). FDA records list one 510(k) clearance for Lasag AG. As of , FDA records show no recalls naming K895864.

Clearance record

Decision date
Received
(87 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
Lasag AG 6440 Flying Cloud Dr., #117, Eden Prairie MN
Third party review
No

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