FDA 510(k)

Precision1, Precision1 for Astigmatism

K-Number: K230785 · 2023-04-20

Decision Date2023-04-20

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Precision1, Precision1 for Astigmatism is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Laboratories, Inc.. It received FDA 510(k) clearance on 2023-04-20 under 510(k) number K230785. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Precision1, Precision1 for Astigmatism?

Precision1, Precision1 for Astigmatism is a medical device that received FDA 510(k) clearance on 2023-04-20. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K230785.

When did Precision1, Precision1 for Astigmatism receive FDA 510(k) clearance?

Precision1, Precision1 for Astigmatism received FDA 510(k) clearance on 2023-04-20, under 510(k) number K230785.

Who is the listed applicant for Precision1, Precision1 for Astigmatism?

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

What is the FDA product code for Precision1, Precision1 for Astigmatism?

The FDA product code for Precision1, Precision1 for Astigmatism is LPL.

Other records listing Alcon Laboratories, Inc. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.