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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 the device name listed in this FDA 510(k) record. The listed applicant is Lutronic Corporation. It received FDA 510(k) clearance on 2016-10-05 under 510(k) 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. The listed applicant is Lutronic Corporation. The 510(k) number is K153769.

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

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

Who is the listed applicant for R:GEN Laser System?

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

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

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

Other records listing Lutronic Corporation as applicant

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Related Devices (Code: HQF)

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.

K252979Voyager DSLT (430840610)Belkin Vision, Ltd.K251507INTEGRE LIOQuantel MedicalK251772Navilas Laser System 577sl (156691)Od-Os GmbHK243014EyeQ nanoECPEyeq, Inc.K240615Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc.K242397LYNX PhotocoagulatorNorlase Aps

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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