510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851557Substantially Equivalent

Anesthesiometer

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

K851557 is the FDA 510(k) clearance record for ANESTHESIOMETER, a class I device, cleared for Luneau SA on under FDA product code HJC (Esthesiometer, Ocular). FDA records list 3 510(k) clearances for Luneau SA, from to . As of , FDA records show no recalls naming K851557.

Clearance record

Decision date
Received
(44 days to decision)
Product code
HJC Esthesiometer, Ocular
Regulation
21 CFR 886.1040
Device class
Class I
Review panel
Ophthalmic
Applicant
Luneau SA Bp 252, Chartres Cedex, FR
Third party review
No

Clearances, product code HJC

Trailing 12 months

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

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