Home / 510(k) Clearances / K170247

510(k) K170247

Lacriflow CL by Kaneka Pharma America, LLC — Product Code OKS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2017
Date Received
January 27, 2017
Clearance Type
Special
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 Kaneka Pharma America, LLC

  • K192068 — i-ED COIL (April 25, 2020)
  • K121301 — XPRESSWAY RX CATHETER (6F LD-VERISON) (July 30, 2012)
  • K101839 — KANEKA PHARMA AMERICA XPRESS-WAY RX (October 22, 2010)

Other clearances for product code OKS

  • K201892 — Ritleng®+ and Ritleng®+ PVP (March 11, 2021)
  • K201606 — LacriJet® (December 18, 2020)
  • 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)
  • K113316 — DCS LACRIMAL STENT (November 8, 2012)