Cleared Traditional

The Evolve System with the Transform Applicator (K231495) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K231495 · Inmode , Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Oct 2023
Decision
143d
Days
Class 2
Risk

K231495 is an FDA 510(k) clearance for the The Evolve System with the Transform Applicator. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Inmode , Ltd. (Yokneam Illit, IL). The FDA issued a Cleared decision on October 13, 2023 after a review of 143 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 Inmode , Ltd. devices

Submission Details

510(k) Number K231495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2023
Decision Date October 13, 2023
Days to Decision 143 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
28d slower than avg
Panel avg: 115d · This submission: 143d
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

Hogan Lovells US LLP
Janice M. Hogan

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
NCT05398159 Completed Interventional Industry-sponsored

Trim II for Noninvasive Lipolysis and Circumference Reduction of Abdomen.

Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference Reduction of Abdomen

75
Patients (actual)
5
Sites
Treatment
Purpose
Open label
Masking
Condition studied Circumference Reduction of Abdomen
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor InMode MD Ltd. (industry)
Started 2021-03-10 → Primary completion 2022-10-30
Primary outcome
Evaluation of Change in Abdomen Circumference Using Tape Measurements in cm at the 3 Months Follow-up Visit Comparing to Baseline.
Secondary outcome
Percentage of Participants With Baseline and 3 Month Abdomen Photographs Correctly Identified by Two Blind Evaluators
View full study on ClinicalTrials.gov

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 619
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K231495.
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Cross Vascular RF Generator and Footswitch (optional accessory)
K232809 · Cross Vascular, Inc. · Oct 2023
Disposable electrosurgical pencil (MD1000)
K232460 · Shenzhen Mecun Medical Supply Co., Ltd. · Oct 2023