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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 the device name listed in this FDA 510(k) record. The listed applicant is The Lifestyle Company, Inc.. It received FDA 510(k) clearance on 2020-05-15 under 510(k) 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. The listed applicant is The Lifestyle Company, Inc.. The 510(k) number is K200747.

When did PuriLens Plus Preservative Free Saline receive FDA 510(k) clearance?

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

Who is the listed applicant for PuriLens Plus Preservative Free Saline?

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

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

The FDA product code for PuriLens Plus Preservative Free Saline is LPN.

Related Devices (Code: LPN)

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.

K253795MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionMenicon Co, Ltd.K222541Bausch + Lomb Preservative Free Lubricating and Rewetting DropsBausch & Lomb, IncorporatedK221263Aqua Naina Plus Sterile Saline SolutionChemtex USA, Inc.K202932ABT12 multi-purpose solutionBausch & Lomb, IncorporatedK210051OTE MPS 045 Multi-purpose Lens Care SolutionOte North America, LLCK193441Aqua Naina Sterile Saline SolutionChemtex USA, Inc.

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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