Home / 510(k) Clearances / K924198

510(k) K924198

MODIFIED SITE FIBER OPTIC MODULE by Chiron Vision Corp. — Product Code FCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1992
Date Received
August 20, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Headlight, Fiberoptic Focusing
Device Class
Class II
Regulation Number
886.4335
Review Panel
OP
Submission Type

Other clearances by Chiron Vision Corp.

  • K970727 — MPORT FOLDABLE LENS PLACEMENT SYSTEM (December 17, 1997)
  • K972808 — HANSATOME MICROKERATOME (October 24, 1997)
  • K960414 — SYNERGIST POWER PACK (April 24, 1996)
  • K944993 — IOLAB.SITE CD PHACOEMULSIFICATION MODULE (October 12, 1995)
  • K944995 — IOLAB/SITE PERISTALTIC MODULE (October 5, 1995)
  • K951292 — PASSPORT FOLDABLE LENS PLACEMENT SYSTEM (June 2, 1995)
  • K944994 — IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE (March 14, 1995)
  • K941550 — AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT (November 22, 1994)
  • K935233 — IOLAB LACRIMAL DUCT CATHETER (September 15, 1994)
  • K925606 — OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS (August 29, 1994)

Other clearances for product code FCT

  • K960767 — LIGHT COMMANDER (August 26, 1996)
  • K883480 — MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE (August 24, 1988)
  • K802770 — FIBER OPTIC HEADLIGHT #60-0766766 (December 11, 1980)
  • K802769 — FIBER OPTIC HEADLIGHT #60-0765 (December 11, 1980)
  • K780433 — FIBER OPTIC ADJUSTABLE HEADLIGHT (June 13, 1978)