FDA 510(k)

LunulaLaser

K-Number: K153164 · 2016-06-03

Decision Date2016-06-03

Product CodePDZ

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

LunulaLaser is the device name listed in this FDA 510(k) record. The listed applicant is Erchonia Medical, Inc.. It received FDA 510(k) clearance on 2016-06-03 under 510(k) number K153164. 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 LunulaLaser?

LunulaLaser is a medical device that received FDA 510(k) clearance on 2016-06-03. The listed applicant is Erchonia Medical, Inc.. The 510(k) number is K153164.

When did LunulaLaser receive FDA 510(k) clearance?

LunulaLaser received FDA 510(k) clearance on 2016-06-03, under 510(k) number K153164.

Who is the listed applicant for LunulaLaser?

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

What is the FDA product code for LunulaLaser?

The FDA product code for LunulaLaser 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.K190034REMY Medical Therapy Laser SystemFootdocprenur, LLC

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.