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FDA 510(k)

Lacriflow CL

K-Number: K170247 · 2017-04-18

Decision Date2017-04-18
Product CodeOKS
DecisionSubstantially Equivalent

Device Summary

Lacriflow CL is the device name listed in this FDA 510(k) record. The listed applicant is Kaneka Pharma America, LLC. It received FDA 510(k) clearance on 2017-04-18 under 510(k) number K170247. The device is classified under product code OKS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lacriflow CL?

Lacriflow CL is a medical device that received FDA 510(k) clearance on 2017-04-18. The listed applicant is Kaneka Pharma America, LLC. The 510(k) number is K170247.

When did Lacriflow CL receive FDA 510(k) clearance?

Lacriflow CL received FDA 510(k) clearance on 2017-04-18, under 510(k) number K170247.

Who is the listed applicant for Lacriflow CL?

The FDA 510(k) record lists Kaneka Pharma America, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lacriflow CL?

The FDA product code for Lacriflow CL is OKS.

Other records listing Kaneka Pharma America, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: OKS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.