Home / 510(k) Clearances / K864381

510(k) K864381

LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM by Luxtec Corp. — Product Code FWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1986
Date Received
November 5, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Television, Surgical, With Audio
Device Class
Class I
Regulation Number
878.4160
Review Panel
SU
Submission Type

Other clearances by Luxtec Corp.

  • K973193 — LUXSCOPE (November 21, 1997)
  • K970642 — TENOSCOPE (May 21, 1997)
  • K970562 — TENOSNARE (May 14, 1997)
  • K950960 — REDDY ILLUMINATOR (September 8, 1995)
  • K895248 — IMS5000 ILLUMINATED LOUPES (September 15, 1989)
  • K890716 — LUXTEC ACO SERIES 4000 LIGHT SOURCE (April 26, 1989)
  • K864387 — LUXTEC FIBEROPTIC CABLES (May 22, 1987)
  • K864382 — FRAZIER SUCTION TUBE (January 14, 1987)
  • K864383 — LUXTEC, KILLIAN AND VIENNA NASAL SPECULUMS (January 14, 1987)
  • K864385 — LUXTEC LIGHT SOURCES (January 13, 1987)

Other clearances for product code FWC

  • K890119 — BR-S601MU (SURGICAL VIDEO RECORDER) (January 24, 1989)
  • K854988 — KY-M280U SURGICAL CAMERA (January 24, 1986)