Cleared Traditional

K103014 - MIRADRY SYSTEM

K103014 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 OUB cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K103014 · Miramar Labs, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
107d
Days
Class 2
Risk

K103014 is an FDA 510(k) clearance for the MIRADRY SYSTEM. Classified as Instrument For Treatment Of Hyperhidrosis (product code OUB), Class II - Special Controls.

Submitted by Miramar Labs, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on January 28, 2011 after a review of 107 days - within the typical 510(k) review window.

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 - K103014

510(k) Number K103014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2010
Decision Date January 28, 2011
Days to Decision 107 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 115d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

OUB Device Classification - Class 2, Special Controls

Product Code OUB Instrument For Treatment Of Hyperhidrosis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Soft-tissue Coagulation
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00931359 Completed Interventional Industry-sponsored

Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis

A Prospective, Multicenter, Parallel, Randomized, Blinded Study of the Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis

120
Patients (actual)
7
Sites
Treatment
Purpose
Double blind
Masking
Condition studied Primary Focal Hyperhidrosis, Axilla
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Dee Anna Glaser, MD
Sponsor Miramar Labs (industry)
Started 2009-06-01 → Primary completion 2009-12-01 → Completed 2010-12-01
Primary outcome
Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days.
Secondary outcome
Percentage of Subjects That Report an HDSS Score of 1 or 2 at the 6 Month Follow-up Visit.
View full study on ClinicalTrials.gov