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510(k) K864380

LUTEX HEADLIGHT SYSTEMS by Luxtec Corp. — Product Code FST

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1986
Date Received
November 5, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Fiberoptic
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Luxtec Corp.

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  • 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)

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