510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964774Substantially Equivalent

Punctum Plugs & Ready-Set Punctal Plugs

Fci Ophthalmics, Inc., Marshfield Hills MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964774 is the FDA 510(k) clearance record for PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS, cleared for Fci Ophthalmics, Inc. on under FDA product code LZU (Plug, Punctum). FDA records list 13 510(k) clearances for Fci Ophthalmics, Inc., from to . As of , FDA records show no recalls naming K964774.

Clearance record

Decision date
Received
(59 days to decision)
Product code
LZU Plug, Punctum
Device class
Unclassified
Review panel
Unknown
Applicant
Fci Ophthalmics, Inc. P.O. Box 465, Marshfield Hills MA
510(k) summary
Statement
Third party review
No

Clearances, product code LZU

Trailing 12 months

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

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