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510(k) K091246

ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M) by Trumpf Medizin Systeme GmbH + Co. KG — Product Code FSS

K091246 is an FDA 510(k) premarket notification submitted by Trumpf Medizin Systeme GmbH + Co. KG for the device "ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M)". The FDA issued a decision of Substantially Equivalent on September 28, 2009. The device falls under product code FSS (Light, Surgical, Floor Standing), a Class II device regulated under 21 CFR 878.4580.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2009
Date Received
April 27, 2009
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Floor Standing
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances for product code FSS

  • K003489 — NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT G (February 2, 2001)
  • K984124 — AESCULAP XENON LIGHT SOURCE (February 1, 1999)
  • K981962 — CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE (August 18, 1998)
  • K981821 — VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR (July 29, 1998)
  • K981469 — CERMAX300 LIGHTSOURCE (July 9, 1998)
  • K980044 — XENON 300MX (April 3, 1998)
  • K970886 — HANAULUX BLUE 80 HOSPITAL (April 16, 1997)
  • K961971 — Q-5000 (June 28, 1996)
  • K961074 — LIGHTSOURCE OR ILLUMINATOR (April 30, 1996)
  • K930711 — TRI*STAR (July 30, 1993)

FDA data resources