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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 a medical device manufactured by Optics Laboratory, Inc.. It received FDA 510(k) clearance on 2016-08-11 under approval 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. It is manufactured by Optics Laboratory, Inc.. The 510(k) number is K161622.

When was LensGiene Sterile Saline Solution approved by the FDA?

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

What company makes LensGiene Sterile Saline Solution?

LensGiene Sterile Saline Solution is manufactured by Optics Laboratory, Inc..

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

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

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Official Source

View on FDA Database →

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

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