510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182659Substantially Equivalent

Galilei G6 Lens Professional

Sis Ag, Surgical Instrument Systems, Port, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182659 is the FDA 510(k) clearance record for Galilei G6 Lens Professional, a class II device, cleared for Sis Ag, Surgical Instrument Systems on under FDA product code MXK (Device, Analysis, Anterior Segment). FDA records list one 510(k) clearance for Sis Ag, Surgical Instrument Systems. As of , FDA records show no recalls naming K182659.

Clearance record

Decision date
Received
(303 days to decision)
Product code
MXK Device, Analysis, Anterior Segment
Regulation
21 CFR 886.1850
Device class
Class II
Review panel
Ophthalmic
Applicant
Sis Ag, Surgical Instrument Systems Allmendstrasse 11, Port, CH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MXK

Trailing 12 months
2 clearances under product code MXK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MXK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260