BTL-9000; BTL-9000 RADIOFREQUENCY MODULE— 510(k) K134040

Name: FDA 510(k) clearance K134040
Creator: U.S. Food and Drug Administration
Published: 2014-09-10

Substantially Equivalent

Btl Industries, Ltd.

FDA 510(k) clearance K134040 for BTL-9000; BTL-9000 RADIOFREQUENCY MODULE, Substantially Equivalent on 2014-09-10. Applicant: Btl Industries, Ltd.. Device class: 2.

Clearance details

Applicant: Btl Industries, Ltd.
Product code: Code OLI
Device class: Class 2
Regulation: 21 CFR 878.5400
Advisory panel: General, Plastic Surgery
Date received: 2013-12-31
Decision date: 2014-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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