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FDA 510(k)

R:GEN

K-Number: K220974 · 2022-12-27

ApplicantLutronic Vision, Inc.
Decision Date2022-12-27
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

R:GEN is the device name listed in this FDA 510(k) record. The listed applicant is Lutronic Vision, Inc.. It received FDA 510(k) clearance on 2022-12-27 under 510(k) number K220974. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R:GEN?

R:GEN is a medical device that received FDA 510(k) clearance on 2022-12-27. The listed applicant is Lutronic Vision, Inc.. The 510(k) number is K220974.

When did R:GEN receive FDA 510(k) clearance?

R:GEN received FDA 510(k) clearance on 2022-12-27, under 510(k) number K220974.

Who is the listed applicant for R:GEN?

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

What is the FDA product code for R:GEN?

The FDA product code for R:GEN is HQF.

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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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