Cleared Traditional

K160141 - miraDry System

K160141 is an FDA 510(k) clearance for miraDry System, manufactured by Miramar Labs, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEY cleared through the Traditional 510(k) pathway after a 284-day FDA review.

K160141 · Miramar Labs, Inc. · General & Plastic Surgery device
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Oct 2016
Decision
284d
Days
Class 2
Risk

K160141 is an FDA 510(k) clearance for the miraDry System. Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by Miramar Labs, Inc. (Santa Clara, US). The FDA issued a Cleared decision on October 31, 2016 after a review of 284 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Miramar Labs, Inc. devices

FDA 510(k) Submission Details - K160141

510(k) Number K160141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2016
Decision Date October 31, 2016
Days to Decision 284 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
169d slower than avg
Panel avg: 115d · This submission: 284d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NEY Device Classification - Class 2, Special Controls

Product Code NEY System, Ablation, Microwave And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - NEY System, Ablation, Microwave And Accessories

All 40
Devices cleared under the same product code (NEY) and FDA review panel - the closest regulatory comparables to K160141.
miraDry System
K180396 · Miramar Labs, Inc. · Mar 2018
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K162449 · AngioDynamics, Inc. · May 2017
Emprint Ablation System
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K061865 · Guidant Corp. · Jul 2006