Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION

K-Number: K031193 · 2003-07-03

ApplicantAlcon, Inc.
Decision Date2003-07-03
Product CodeLPN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Alcon, Inc.. It received FDA 510(k) clearance on 2003-07-03 under 510(k) number K031193. 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 SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION?

SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION is a medical device that received FDA 510(k) clearance on 2003-07-03. The listed applicant is Alcon, Inc.. The 510(k) number is K031193.

When did SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION receive FDA 510(k) clearance?

SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION received FDA 510(k) clearance on 2003-07-03, under 510(k) number K031193.

Who is the listed applicant for SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION?

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

What is the FDA product code for SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION?

The FDA product code for SOFT (HYDROPHILIC) CONTACT LENS CARE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Alcon, 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.

K071236ALCON MULTI-PURPOSE SOLUTIONK040231INTELIPORT OCCLUDING DEVICE

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.

↑