Cleared Traditional

K233604 - BTL-785S (FDA 510(k) Clearance)

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

K233604 · BTL Industries, Inc. · General & Plastic Surgery device
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Mar 2024
Decision
140d
Days
Class 2
Risk

K233604 is an FDA 510(k) clearance for the BTL-785S. 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. (Marlborough, US). The FDA issued a Cleared decision on March 28, 2024 after a review of 140 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 BTL Industries, Inc. devices

Submission Details

510(k) Number K233604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2023
Decision Date March 28, 2024
Days to Decision 140 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
26d slower than avg
Panel avg: 114d · This submission: 140d
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.

Clinical Evidence

ClinicalTrials.gov
NCT05831332 Completed Interventional Industry-sponsored

Safety and Efficacy of the BTL-785F Device for Non-invasive Reduction of Submental Fat

56
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Skin Laxity
Study design Single group
Eligibility All sexes · 21 Years+ · Healthy volunteers accepted
Sponsor BTL Industries Ltd. (industry)
Started 2023-03-06 → Primary completion 2023-08-30 → Completed 2023-10-25
Primary outcome
Change of submental fat thickness
Secondary outcome
Evaluation the effect on submental skin laxity
Study completed - no results published. This trial concluded in 2023 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

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 2294
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K233604.
ARION ARC System
K253917 · Plasma Surgical, Inc. · Apr 2026
Ascblue (8010)
K253777 · Ascblue Corporation · Apr 2026
Multifunctional Operational Dissectors (Electrosurgical Pencils)
K260466 · Zhejiang shuyou Surgical Instrument Co., Ltd. · Apr 2026
SYNERJET PRO (SP-1002)
K260397 · Hironic Co., Ltd. · Apr 2026
Prana System
K253405 · Prana Surgical · Apr 2026
AVENTIX PFX System (PFX01)
K260255 · Aventix Medical, Inc. · Mar 2026