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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is BTL Industries, Inc.. It received FDA 510(k) clearance on 2017-01-12 under 510(k) 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. The listed applicant is BTL Industries, Inc.. The 510(k) number is K163176.

When did Exilis XP II receive FDA 510(k) clearance?

Exilis XP II received FDA 510(k) clearance on 2017-01-12, under 510(k) number K163176.

Who is the listed applicant for Exilis XP II?

The FDA 510(k) record lists BTL Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Exilis XP II?

The FDA product code for Exilis XP II is PBX.

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Other records listing BTL Industries, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252963BTL-899TTK253750BTL-785NEHK252561BTL-754FFK250309BTL-199K243290BTL-785MJK241516BTL-398

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Related Devices (Code: PBX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.K260647SPECCHIOEl.En S.P.A.K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.K252888NeoSculpt PlusS&M Medical Co., Ltd.K250734OptiLUV DevicePollogen, Ltd.K250916WinForth (LM-E470KA)Shenzhen Leaflife Technology Co., Ltd.

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.

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