510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003489Substantially Equivalent

Next General M20 Surgical Light; Next Generation M16 Minor Surgery Light; Next Generation Spotlight; Next Generation M8

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

K003489 is the FDA 510(k) clearance record for NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8, a class II device, cleared for Medical Illumination International, Inc. on under FDA product code FSS (Light, Surgical, Floor Standing). FDA records list 5 510(k) clearances for Medical Illumination International, Inc., from to . As of , FDA records show no recalls naming K003489.

Clearance record

Decision date
Received
(81 days to decision)
Product code
FSS Light, Surgical, Floor Standing
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
Statement
Third party review
No

Clearances, product code FSS

Trailing 12 months

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

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