510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K140812Substantially Equivalent

Mi-750 Procedural/minor Surgical Light

Medical Illumination International, Inc, San Fernando CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140812 is the FDA 510(k) clearance record for MI-750 PROCEDURAL/MINOR SURGICAL LIGHT, a class II device, cleared for Medical Illumination International, Inc. on under FDA product code FSY (Light, Surgical, Ceiling Mounted). FDA records list 5 510(k) clearances for Medical Illumination International, Inc., from to . As of , FDA records show no recalls naming K140812.

Clearance record

Decision date
Received
(128 days to decision)
Product code
FSY Light, Surgical, Ceiling Mounted
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Medical Illumination International, Inc. 547 Library St., San Fernando CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FSY

Trailing 12 months

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

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