510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945114Substantially Equivalent

Visitec Scleral Plug

Visitec Co., Sarasota FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945114 is the FDA 510(k) clearance record for VISITEC SCLERAL PLUG, a class II device, cleared for Visitec Co. on under FDA product code LXP (Plug, Scleral). FDA's definition for product code LXP reads: "Intended to provide temporary closure of a scleral incision during an ophthalmic procedure". FDA records list 49 510(k) clearances for Visitec Co., from to . As of , FDA records show no recalls naming K945114.

Clearance record

Decision date
Received
(128 days to decision)
Product code
LXP Plug, Scleral
Regulation
21 CFR 886.4155
Device class
Class II
Review panel
Ophthalmic
Applicant
Visitec Co. 7575 Commerce Ct., Sarasota FL
510(k) summary
Summary
Third party review
No

Clearances, product code LXP

Trailing 12 months

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

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