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510(k) K935233

IOLAB LACRIMAL DUCT CATHETER by Chiron Vision Corp. — Product Code OKS

K935233 is an FDA 510(k) premarket notification submitted by Chiron Vision Corp. for the device "IOLAB LACRIMAL DUCT CATHETER". The FDA issued a decision of Substantially Equivalent on September 15, 1994. The device falls under product code OKS (Lacrimal Stents And Intubation Sets), a Class U device. Chiron Vision Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1994
Date Received
November 1, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lacrimal Stents And Intubation Sets
Device Class
Class U
Regulation Number
Review Panel
OP
Submission Type

Lacrimal stents and intubations sets are intended to repair the lacrimal drainage system. Lacrimal stents and intubations sets are indicated for, but limited to, the treatment of epiphora in infants and adults; canalicular pathologies such as stenosis; obstruction or laceration; and conditions requiring dacryocystorhinostomy (conventional or laser); or imperforation of the nasolacrimal duct in an infant.

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)
  • K925606 — OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS (August 29, 1994)
  • K926412 — MICRON-SCOPE II (July 19, 1994)

Other clearances for product code OKS

  • K201892 — Ritleng®+ and Ritleng®+ PVP (March 11, 2021)
  • K201606 — LacriJet® (December 18, 2020)
  • K170247 — Lacriflow CL (April 18, 2017)
  • K161373 — Nunchaku (November 3, 2016)
  • K160710 — Oasis Lacrimal Intubation Set (May 13, 2016)
  • K142914 — DacryoCATH (January 12, 2015)
  • K140290 — STOPLOSS JONES TUBE (December 2, 2014)
  • K130375 — SELF-RETAINING BICANALICULUS INTUBATON SET II (December 4, 2013)
  • K123831 — OPHTACATH KIT (July 29, 2013)
  • K120886 — LACRIFAST (December 17, 2012)

FDA data resources