Linvatec 300W Xenon Light Source

• • Terminated Z-1531-05 FDA Unclassified (pre-2012) ·initiated 1 Aug 2005

  Through the complaint handling system, the company has determine there are performance issued involving the LS7500, 300 Watt Xenon Light Source. The performance issues result in a low light output that can create poor illumination of the surgical site.

510(k) Number

K031994 ↗

FDA Product Code

GCT

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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