Luxtec Fiberoptic Cables

• • Terminated Z-0698-2007 FDA Unclassified (pre-2012) ·initiated 7 Feb 2007

  Light Degradation in transmission-A film may deposit on the front face and limit transmission of light

510(k) Number

K864387 ↗

FDA Product Code

EQH

Device Class

Class I

Regulation

21 CFR Part 874.4350

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Frazier Suction Tube

  Class I

  FDA 510(k) K864382 Active Cleared 14 Jan 1987

• Lutex Headlight Systems

  Class II

  FDA 510(k) K864380 Active Cleared 19 Nov 1986

• Luxtec Aco Series 4000 Light Source

  Class II

  FDA 510(k) K890716 Active Cleared 26 Apr 1989

• Luxtec Retractors, Luxtec Specialty Retractors

  Class I

  FDA 510(k) K864384 Active Cleared 19 Nov 1986

• Luxscope

  Class II

  FDA 510(k) K973193 Active Cleared 21 Nov 1997

• Luxtec Loupes for Surgical Vision

  Class I

  FDA 510(k) K864386 Active Cleared 17 Nov 1986

See all devices from Luxtec Corp. →