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FDA 510(k)

R:GEN Laser System

K-Number: K153769 · 2016-10-05

ApplicantLutronic Corporation
Decision Date2016-10-05
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

R:GEN Laser System is a medical device manufactured by Lutronic Corporation. It received FDA 510(k) clearance on 2016-10-05 under approval number K153769. 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 Laser System?

R:GEN Laser System is a medical device that received FDA 510(k) clearance on 2016-10-05. It is manufactured by Lutronic Corporation. The 510(k) number is K153769.

When was R:GEN Laser System approved by the FDA?

R:GEN Laser System received FDA 510(k) clearance on 2016-10-05, under approval number K153769.

What company makes R:GEN Laser System?

R:GEN Laser System is manufactured by Lutronic Corporation.

What is the FDA product code for R:GEN Laser System?

The FDA product code for R:GEN Laser System is HQF.

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

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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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