510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894162Substantially Equivalent

Optisol

Chiron Ophthalmics, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894162 is the FDA 510(k) clearance record for OPTISOL, cleared for Chiron Ophthalmics on under FDA product code LYX (Media, Corneal Storage). FDA records list 10 510(k) clearances for Chiron Ophthalmics, from to . As of , FDA records show no recalls naming K894162.

Clearance record

Decision date
Received
(212 days to decision)
Product code
LYX Media, Corneal Storage
Device class
Unclassified
Review panel
Unknown
Applicant
Chiron Ophthalmics 9342 Jeronimo Rd., Irvine CA
Third party review
No

Clearances, product code LYX

Trailing 12 months

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

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