510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K022413Substantially Equivalent

Luneau 3 Mirror Lens

Luneau SA, Chartres Cedex, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K022413 is the FDA 510(k) clearance record for LUNEAU 3 MIRROR LENS, a class II device, cleared for Luneau SA on under FDA product code HJK (Lens, Contact, Polymethylmethacrylate, Diagnostic). FDA records list 3 510(k) clearances for Luneau SA, from to . As of , FDA records show no recalls naming K022413.

Clearance record

Decision date
Received
(62 days to decision)
Product code
HJK Lens, Contact, Polymethylmethacrylate, Diagnostic
Regulation
21 CFR 886.1385
Device class
Class II
Review panel
Ophthalmic
Applicant
Luneau SA Bp 252, Chartres Cedex, FR
510(k) summary
Statement
Third party review
No

Clearances, product code HJK

Trailing 12 months

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

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