Cleared Traditional

K140255 - STOP U (PACKED BLACK USA)

Also marketed or referenced as:
STOP U (PACKED WHITE USA)

K140255 is an FDA 510(k) clearance for STOP U (PACKED BLACK USA), manufactured by Pollogen, Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K140255 · Pollogen, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
103d
Days
Class 2
Risk

K140255 is an FDA 510(k) clearance for the STOP U (PACKED BLACK USA). Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Pollogen, Ltd. (Washington, US). The FDA issued a Cleared decision on May 14, 2014 after a review of 103 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 Pollogen, Ltd. devices

FDA 510(k) Submission Details - K140255

510(k) Number K140255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2014
Decision Date May 14, 2014
Days to Decision 103 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
12d faster than avg
Panel avg: 115d · This submission: 103d
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
NCT01858415 Unknown Interventional Industry-sponsored

Evaluation of Safety and Efficacy of TriPollar Device for Treatment of Wrinkles

Evaluation of Safety and Efficacy of TriPollar Device for Treatment of Wrinkles and Rhytides

40
Patients (est.)
2
Sites
Treatment
Purpose
Open label
Masking
Condition studied Facial Wrinkles
Study design Single group
Eligibility All sexes · 35 Years+ · Healthy volunteers accepted
Principal investigator Mira Barki, PhD
Sponsor Pollogen (industry)
Started 2013-04-01 Primary completion 2013-12-01
Primary outcome
Safety of TriPollar
View full study on ClinicalTrials.gov

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 2002
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K140255.
MINNIE
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K140495 · Boston Scientific Corp · Apr 2014
BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUENCY ELECTROSURGICAL GENERATOR
K134054 · Bovie Medical Corporation · Mar 2014