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510(k) K890716

LUXTEC ACO SERIES 4000 LIGHT SOURCE by Luxtec Corp. — Product Code FCW

K890716 is an FDA 510(k) premarket notification submitted by Luxtec Corp. for the device "LUXTEC ACO SERIES 4000 LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on April 26, 1989. The device falls under product code FCW (Light Source, Fiberoptic, Routine), a Class II device regulated under 21 CFR 876.1500. Luxtec Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1989
Date Received
February 13, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Source, Fiberoptic, Routine
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
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)
  • K864387 — LUXTEC FIBEROPTIC CABLES (May 22, 1987)
  • K864383 — LUXTEC, KILLIAN AND VIENNA NASAL SPECULUMS (January 14, 1987)
  • K864382 — FRAZIER SUCTION TUBE (January 14, 1987)
  • K864385 — LUXTEC LIGHT SOURCES (January 13, 1987)
  • K864865 — SPECULUM, VAGINAL, METAL FIBEROPTIC (January 9, 1987)

Other clearances for product code FCW

  • K131226 — NOVAPROBE LED LIGHT SOURCE (July 24, 2014)
  • K123956 — POWER LED 175 (January 25, 2013)
  • K123359 — OVS1 VIDEO SYSTEM (December 19, 2012)
  • K121724 — ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 (September 20, 2012)
  • K093792 — LED LIGHT SOURCE (March 18, 2010)
  • K091968 — KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C (September 14, 2009)
  • K082813 — STRYKER LED LIGHTSOURCE (December 19, 2008)
  • K081477 — LUXTEC MLX LIGHT SOURCE (June 18, 2008)
  • K032430 — ACUEITY MEDICAL LIGHT SOURCE (September 5, 2003)
  • K012265 — METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 (October 17, 2001)

FDA data resources