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

FDA 510(k)

MaxiTears Contacts PF

K-Number: K182984 · 2019-07-24

ApplicantOmnivision AG
Decision Date2019-07-24
Product CodeMRC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MaxiTears Contacts PF is a medical device manufactured by Omnivision AG. It received FDA 510(k) clearance on 2019-07-24 under approval number K182984. The device is classified under product code MRC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MaxiTears Contacts PF?

MaxiTears Contacts PF is a medical device that received FDA 510(k) clearance on 2019-07-24. It is manufactured by Omnivision AG. The 510(k) number is K182984.

When was MaxiTears Contacts PF approved by the FDA?

MaxiTears Contacts PF received FDA 510(k) clearance on 2019-07-24, under approval number K182984.

What company makes MaxiTears Contacts PF?

MaxiTears Contacts PF is manufactured by Omnivision AG.

What is the FDA product code for MaxiTears Contacts PF?

The FDA product code for MaxiTears Contacts PF is MRC.

Related Devices (Code: MRC)

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.