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FDA 510(k)

PURILENS SALINE SOLUTION

K-Number: K002319 · 2000-08-30

ApplicantPurilens, Inc.
Decision Date2000-08-30
Product CodeLPN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PURILENS SALINE SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Purilens, Inc.. It received FDA 510(k) clearance on 2000-08-30 under 510(k) number K002319. 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 SALINE SOLUTION?

PURILENS SALINE SOLUTION is a medical device that received FDA 510(k) clearance on 2000-08-30. The listed applicant is Purilens, Inc.. The 510(k) number is K002319.

When did PURILENS SALINE SOLUTION receive FDA 510(k) clearance?

PURILENS SALINE SOLUTION received FDA 510(k) clearance on 2000-08-30, under 510(k) number K002319.

Who is the listed applicant for PURILENS SALINE SOLUTION?

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

What is the FDA product code for PURILENS SALINE SOLUTION?

The FDA product code for PURILENS SALINE SOLUTION is LPN.

Related Clinical Trials

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.

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Other records listing Purilens, Inc. 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.

K991965PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES

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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