Cleared Traditional

K172529 - Vivaer ARC Stylus

K172529 is an FDA 510(k) clearance for Vivaer ARC Stylus, manufactured by Aerin Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K172529 · Aerin Medical, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Dec 2017
Decision
106d
Days
Class 2
Risk

K172529 is an FDA 510(k) clearance for the Vivaer ARC Stylus. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Aerin Medical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 5, 2017 after a review of 106 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 Aerin Medical, Inc. devices

FDA 510(k) Submission Details - K172529

510(k) Number K172529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2017
Decision Date December 05, 2017
Days to Decision 106 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
9d faster than avg
Panel avg: 115d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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
NCT02914236 Completed Interventional Industry-sponsored

Treatment of Nasal Airway Obstruction Using the Aerin Medical Device

A Prospective, Multi-Center Non-Randomized Study to Evaluate Treatment of Nasal Airway Obstruction Using the Aerin Medical Device

50
Patients (actual)
9
Sites
Treatment
Purpose
Open label
Masking
Condition studied Nasal Obstruction
Study design Single group
Eligibility All sexes · 22 Years+
Principal investigator Scott Wolf, MD
Sponsor Aerin Medical (industry)
Started 2016-09-27 → Primary completion 2017-07-21 → Completed 2017-08-18
Primary outcome
Improvement in NOSE Score
Secondary outcome
NOSE Responder Rate
View full study on ClinicalTrials.gov

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 2002
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