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510(k) K864386

LUXTEC LOUPES FOR SURGICAL VISION by Luxtec Corp. — Product Code FSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1986
Date Received
November 5, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Loupe, Diagnostic/Surgical
Device Class
Class I
Regulation Number
878.4800
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 FSP

  • K895248 — IMS5000 ILLUMINATED LOUPES (September 15, 1989)
  • K891895 — SURGICAL LOUPES (April 12, 1989)
  • K861749 — 3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE (May 23, 1986)