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FDA 510(k)

LensGiene Sterile Saline Solution

K-Number: K161622 · 2016-08-11

ApplicantOptics Laboratory, Inc.
Decision Date2016-08-11
Product CodeLPN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LensGiene Sterile Saline Solution is the device name listed in this FDA 510(k) record. The listed applicant is Optics Laboratory, Inc.. It received FDA 510(k) clearance on 2016-08-11 under 510(k) number K161622. The device is classified under product code LPN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LensGiene Sterile Saline Solution?

LensGiene Sterile Saline Solution is a medical device that received FDA 510(k) clearance on 2016-08-11. The listed applicant is Optics Laboratory, Inc.. The 510(k) number is K161622.

When did LensGiene Sterile Saline Solution receive FDA 510(k) clearance?

LensGiene Sterile Saline Solution received FDA 510(k) clearance on 2016-08-11, under 510(k) number K161622.

Who is the listed applicant for LensGiene Sterile Saline Solution?

The FDA 510(k) record lists Optics Laboratory, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LensGiene Sterile Saline Solution?

The FDA product code for LensGiene Sterile Saline Solution is LPN.

Related Clinical Trials

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Related Devices (Code: LPN)

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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.

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