Cleared Traditional

K190023 - BTL-084

K190023 is the FDA 510(k) clearance for BTL-084 by BTL Industries, Inc.. It is a Class 2 General & Plastic Surgery device (product code PBX) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K190023 · BTL Industries, Inc. · General & Plastic Surgery device
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Mar 2019
Decision
84d
Days
Class 2
Risk

K190023 is an FDA 510(k) clearance for the BTL-084. Classified as Massager, Vacuum, Radio Frequency Induced Heat (product code PBX), Class II - Special Controls.

Submitted by BTL Industries, Inc. (Marlborough, US). The FDA issued a Cleared decision on March 29, 2019 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all BTL Industries, Inc. devices

Submission Details

510(k) Number K190023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2019
Decision Date March 29, 2019
Days to Decision 84 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
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PBX Massager, Vacuum, Radio Frequency Induced Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Generates Heat In Body Tissues For Minor Relief Of Minor Aches And Pain. Mechanical Massaging To Provide A Temporary Reduction In The Appearance Of Cellulite.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - PBX Massager, Vacuum, Radio Frequency Induced Heat

All 60
Devices cleared under the same product code (PBX) and FDA review panel - the closest regulatory comparables to K190023.
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