Cleared Traditional

K143559 - XP1000 RF

K143559 is the FDA 510(k) clearance for XP1000 RF by BTL Industries, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K143559 · BTL Industries, Inc. · General & Plastic Surgery device
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Jun 2015
Decision
177d
Days
Class 2
Risk

K143559 is an FDA 510(k) clearance for the XP1000 RF. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by BTL Industries, Inc. (Framingham, US). The FDA issued a Cleared decision on June 11, 2015 after a review of 177 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 BTL Industries, Inc. devices

Submission Details

510(k) Number K143559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2014
Decision Date June 11, 2015
Days to Decision 177 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
62d slower than avg
Panel avg: 115d · This submission: 177d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.

Regulatory Consultant

Mmp Medical Associates, LLC
Michail Pankratov

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT02271672 Completed Interventional Industry-sponsored

XP1000 RF Therapy on Waist Circumference Reduction

Effect of the XP1000 RF Therapy on Waist Circumference Reduction

60
Patients (actual)
Treatment
Purpose
Triple
Masking
Condition studied Circumferential Reduction; Waist Circumferential Reduction
Study design Parallel
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Radina Denkova, MD
Sponsor BTL Industries Ltd. (industry)
Started 2014-08-01 → Primary completion 2015-03-01 → Completed 2015-06-01
Primary outcome
Waist Circumferential reduction
Secondary outcome
Adverse Events
Study completed - no results published. This trial concluded in 2015 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

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All 1062
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