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510(k) K950960

REDDY ILLUMINATOR by Luxtec Corp. — Product Code FFS

K950960 is an FDA 510(k) premarket notification submitted by Luxtec Corp. for the device "REDDY ILLUMINATOR". The FDA issued a decision of Substantially Equivalent on September 8, 1995. The device falls under product code FFS (Image, Illumination, Fiberoptic, For Endoscope), 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
September 8, 1995
Date Received
March 2, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Image, Illumination, Fiberoptic, For Endoscope
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)
  • K895248 — IMS5000 ILLUMINATED LOUPES (September 15, 1989)
  • K890716 — LUXTEC ACO SERIES 4000 LIGHT SOURCE (April 26, 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 FFS

  • K072521 — COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH (November 20, 2007)
  • K061622 — PS SERIES (March 5, 2007)
  • K063309 — TRU-CABLE (January 12, 2007)
  • K061025 — ACCUTECH ENDOLITE PROBE (May 31, 2006)
  • K023633 — SOVIS OPTIQUE'S ENDOSCOPIC CABLE (December 31, 2002)
  • K001698 — MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159 (July 17, 2000)
  • K994084 — SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES (January 20, 2000)
  • K991323 — SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR (July 6, 1999)
  • K983714 — SOLARTEC SOURCE 270, MODEL # 90123 (December 23, 1998)
  • K982462 — FIBER OPTIC ENDOILLUMINATION PROBE (September 14, 1998)

FDA data resources