Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

miraDry System

K-Number: K180396 · 2018-03-15

ApplicantMiramar Labs, Inc.
Decision Date2018-03-15
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

miraDry System is a medical device manufactured by Miramar Labs, Inc.. It received FDA 510(k) clearance on 2018-03-15 under approval number K180396. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the miraDry System?

miraDry System is a medical device that received FDA 510(k) clearance on 2018-03-15. It is manufactured by Miramar Labs, Inc.. The 510(k) number is K180396.

When was miraDry System approved by the FDA?

miraDry System received FDA 510(k) clearance on 2018-03-15, under approval number K180396.

What company makes miraDry System?

miraDry System is manufactured by Miramar Labs, Inc..

What is the FDA product code for miraDry System?

The FDA product code for miraDry System is NEY.

Other Devices by Miramar Labs, Inc.

K160141miraDry System

Related Devices (Code: NEY)

K163105Emprint Ablation SystemCovidien, LLC K160141miraDry SystemMiramar Labs, Inc. K160936Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc. K171358Emprint SX Ablation Platform and AccessoriesCoviden, LLC K162449Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)AngioDynamics, Inc. K163118FLEX Microwave Ablation System and AccessoriesNeuwave Medical, Inc.

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.

↑