Cleared Traditional

K134040 - BTL-9000

Also marketed or referenced as:
BTL-9000 RADIOFREQUENCY MODULE

K134040 is an FDA 510(k) clearance for BTL-9000, manufactured by Btl Industries, Ltd.. The device is a Class 2 General & Plastic Surgery device with product code OLI cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K134040 · Btl Industries, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
253d
Days
Class 2
Risk

K134040 is an FDA 510(k) clearance for the BTL-9000. Classified as Fat Reducing Low Level Laser within the OLI classification (a category for non-invasive low-level laser body contouring systems), Class II - Special Controls.

Submitted by Btl Industries, Ltd. (Waltham, US). The FDA issued a Cleared decision on September 10, 2014 after a review of 253 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5400 - 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, Ltd. devices

FDA 510(k) Submission Details - K134040

510(k) Number K134040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2013
Decision Date September 10, 2014
Days to Decision 253 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 115d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLI Device Classification - Class 2, Special Controls

Product Code OLI Fat Reducing Low Level Laser
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5400
Definition Non-invasive Reduction In Fat Layer For Body Contouring
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 - OLI Fat Reducing Low Level Laser

All 23
Devices cleared under the same product code (OLI) and FDA review panel - the closest regulatory comparables to K134040.
Erchonia Zerona 6 headed scanner EZ6
K150446 · Erchonia Corporation · May 2015
Erchonia Zerona Z6 OTC
K143007 · Erchonia Corporation · Jan 2015
ERCHONIA SHL
K142042 · Erchonia Corporation · Oct 2014
ZERONA
K133718 · Erchonia Corporation · May 2014
ZERONA 2.0 LASER
K123237 · Erchonia Corporation · Jan 2013
ETCHONIA ZERONA ARMS
K121690 · Erchonia Corporation · Aug 2012