REMY Medical Therapy Laser System
K-Number: K190034 · 2019-05-15
ApplicantFootdocprenur, LLC
Decision Date2019-05-15
Product CodePDZ
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
REMY Medical Therapy Laser System is a medical device manufactured by Footdocprenur, LLC. It received FDA 510(k) clearance on 2019-05-15 under approval 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. It is manufactured by Footdocprenur, LLC. The 510(k) number is K190034.
When was REMY Medical Therapy Laser System approved by the FDA?
REMY Medical Therapy Laser System received FDA 510(k) clearance on 2019-05-15, under approval number K190034.
What company makes REMY Medical Therapy Laser System?
REMY Medical Therapy Laser System is manufactured by Footdocprenur, LLC.
What is the FDA product code for REMY Medical Therapy Laser System?
The FDA product code for REMY Medical Therapy Laser System is PDZ.
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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.