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510(k) K895248

IMS5000 ILLUMINATED LOUPES by Luxtec Corp. — Product Code FSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1989
Date Received
August 21, 1989
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)
  • 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)
  • K864865 — SPECULUM, VAGINAL, METAL FIBEROPTIC (January 9, 1987)

Other clearances for product code FSP

  • K891895 — SURGICAL LOUPES (April 12, 1989)
  • K864386 — LUXTEC LOUPES FOR SURGICAL VISION (November 17, 1986)
  • K861749 — 3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE (May 23, 1986)