Exilis XP II
K-Number: K163176 · 2017-01-12
ApplicantBTL Industries, Inc.
Decision Date2017-01-12
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Exilis XP II is a medical device manufactured by BTL Industries, Inc.. It received FDA 510(k) clearance on 2017-01-12 under approval number K163176. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Exilis XP II?
Exilis XP II is a medical device that received FDA 510(k) clearance on 2017-01-12. It is manufactured by BTL Industries, Inc.. The 510(k) number is K163176.
When was Exilis XP II approved by the FDA?
Exilis XP II received FDA 510(k) clearance on 2017-01-12, under approval number K163176.
What company makes Exilis XP II?
Exilis XP II is manufactured by BTL Industries, Inc..
What is the FDA product code for Exilis XP II?
The FDA product code for Exilis XP II is PBX.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.