510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191846Substantially Equivalent

MAXReach Laser Probe

Vortex Surgical, Inc., Chesterfield MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191846 is the FDA 510(k) clearance record for MAXReach Laser Probe, a class II device, cleared for Vortex Surgical, Inc. on under FDA product code HQB (Photocoagulator And Accessories). FDA records list 2 510(k) clearances for Vortex Surgical, Inc., from to . As of , FDA records show no recalls naming K191846.

Clearance record

Decision date
Received
(166 days to decision)
Product code
HQB Photocoagulator And Accessories
Regulation
21 CFR 886.4690
Device class
Class II
Review panel
Ophthalmic
Applicant
Vortex Surgical, Inc. 680 Crown Industrial Ct. Suite F, Chesterfield MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HQB

Trailing 12 months

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

FDA records show no clearances under product code HQB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HQB, 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