Cleared Traditional

K163176 - Exilis XP II

K163176 is an FDA 510(k) clearance for Exilis XP II, manufactured by BTL Industries, Inc.. The device is a Class 2 General & Plastic Surgery device with product code PBX cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K163176 · BTL Industries, Inc. · General & Plastic Surgery device
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Jan 2017
Decision
59d
Days
Class 2
Risk

K163176 is an FDA 510(k) clearance for the Exilis XP II. Classified as Massager, Vacuum, Radio Frequency Induced Heat (product code PBX), Class II - Special Controls.

Submitted by BTL Industries, Inc. (Framingham, US). The FDA issued a Cleared decision on January 12, 2017 after a review of 59 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

FDA 510(k) Submission Details - K163176

510(k) Number K163176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2016
Decision Date January 12, 2017
Days to Decision 59 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
56d faster than avg
Panel avg: 115d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PBX Device Classification - Class 2, Special Controls

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 73
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