FDA 510(k)

REMY Medical Therapy Laser System

K-Number: K190034 · 2019-05-15

Decision Date2019-05-15

Product CodePDZ

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

REMY Medical Therapy Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Footdocprenur, LLC. It received FDA 510(k) clearance on 2019-05-15 under 510(k) number K190034. The device is classified under product code PDZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REMY Medical Therapy Laser System?

REMY Medical Therapy Laser System is a medical device that received FDA 510(k) clearance on 2019-05-15. The listed applicant is Footdocprenur, LLC. The 510(k) number is K190034.

When did REMY Medical Therapy Laser System receive FDA 510(k) clearance?

REMY Medical Therapy Laser System received FDA 510(k) clearance on 2019-05-15, under 510(k) number K190034.

Who is the listed applicant for REMY Medical Therapy Laser System?

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

What is the FDA product code for REMY Medical Therapy Laser System?

The FDA product code for REMY Medical Therapy Laser System is PDZ.

Related Devices (Code: PDZ)

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.

K253960Medicell Mycosis Laser (MCML24004)Medicell Healthcare Co.,LTD K241116Onycho Laser VTerasysd&C, Inc.K211265TFX-LT2000 Therapy LightToefx, Inc.K221363AF LaserShenB Co., Ltd.K153164LunulaLaserErchonia Medical, Inc.

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.