LunulaLaser
K-Number: K153164 · 2016-06-03
ApplicantErchonia Medical, Inc.
Decision Date2016-06-03
Product CodePDZ
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
LunulaLaser is a medical device manufactured by Erchonia Medical, Inc.. It received FDA 510(k) clearance on 2016-06-03 under approval 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. It is manufactured by Erchonia Medical, Inc.. The 510(k) number is K153164.
When was LunulaLaser approved by the FDA?
LunulaLaser received FDA 510(k) clearance on 2016-06-03, under approval number K153164.
What company makes LunulaLaser?
LunulaLaser is manufactured by Erchonia Medical, Inc..
What is the FDA product code for LunulaLaser?
The FDA product code for LunulaLaser is PDZ.
Related Devices (Code: PDZ)
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.