510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904609Substantially Equivalent

Xenon Light Source

Medical Dynamics, Inc., Englewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904609 is the FDA 510(k) clearance record for XENON LIGHT SOURCE, a class II device, cleared for Medical Dynamics, Inc. on under FDA product code HBI (Illuminator, Fiberoptic, Surgical Field). FDA records list 18 510(k) clearances for Medical Dynamics, Inc., from to . As of , FDA records show no recalls naming K904609.

Clearance record

Decision date
Received
(68 days to decision)
Product code
HBI Illuminator, Fiberoptic, Surgical Field
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Medical Dynamics, Inc. 99 Inverness Dr. E., Englewood CO
Third party review
No

Clearances, product code HBI

Trailing 12 months

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

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