Lacriflow CL

FDA 510(k) K170247 · Kaneka Pharma America, LLC

Substantially Equivalent

510(k) numberK170247

Submission

Device name
Lacriflow CL
Applicant
Kaneka Pharma America, LLC
New York, NY, US
Received
January 27, 2017
Decision date
April 18, 2017
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OKS – Lacrimal Stents And Intubation Sets
Device class
Unclassified
Implant
Yes

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…

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Questions and answers

When was Lacriflow CL cleared by the FDA?

Lacriflow CL (K170247) received a 510(k) decision of Substantially Equivalent on April 18, 2017, 81 days after the submission was received.

What is the product code of K170247?

The FDA product code is OKS – Lacrimal Stents And Intubation Sets, a Unclassified device.