510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921214Substantially Equivalent

Ophthalmic Projector

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

K921214 is the FDA 510(k) clearance record for OPHTHALMIC PROJECTOR, a class I device, cleared for Luneau Ophtalmologie SA on under FDA product code HOS (Projector, Ophthalmic). FDA records list 3 510(k) clearances for Luneau Ophtalmologie SA, from to . As of , FDA records show no recalls naming K921214.

Clearance record

Decision date
Received
(90 days to decision)
Product code
HOS Projector, Ophthalmic
Regulation
21 CFR 886.1680
Device class
Class I
Review panel
Ophthalmic
Applicant
Luneau Ophtalmologie SA Bp 252, Chartres Cedex, FR
510(k) summary
Statement
Third party review
No

Clearances, product code HOS

Trailing 12 months

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

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