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FDA 510(k)

PuriLens Plus Preservative Free Saline

K-Number: K200747 · 2020-05-15

ApplicantThe Lifestyle Company, Inc.
Decision Date2020-05-15
Product CodeLPN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PuriLens Plus Preservative Free Saline is a medical device manufactured by The Lifestyle Company, Inc.. It received FDA 510(k) clearance on 2020-05-15 under approval number K200747. 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 PuriLens Plus Preservative Free Saline?

PuriLens Plus Preservative Free Saline is a medical device that received FDA 510(k) clearance on 2020-05-15. It is manufactured by The Lifestyle Company, Inc.. The 510(k) number is K200747.

When was PuriLens Plus Preservative Free Saline approved by the FDA?

PuriLens Plus Preservative Free Saline received FDA 510(k) clearance on 2020-05-15, under approval number K200747.

What company makes PuriLens Plus Preservative Free Saline?

PuriLens Plus Preservative Free Saline is manufactured by The Lifestyle Company, Inc..

What is the FDA product code for PuriLens Plus Preservative Free Saline?

The FDA product code for PuriLens Plus Preservative Free Saline 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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