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FDA 510(k)

BTL-084

K-Number: K190023 · 2019-03-29

ApplicantBTL Industries, Inc.
Decision Date2019-03-29
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BTL-084 is a medical device manufactured by BTL Industries, Inc.. It received FDA 510(k) clearance on 2019-03-29 under approval number K190023. 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 BTL-084?

BTL-084 is a medical device that received FDA 510(k) clearance on 2019-03-29. It is manufactured by BTL Industries, Inc.. The 510(k) number is K190023.

When was BTL-084 approved by the FDA?

BTL-084 received FDA 510(k) clearance on 2019-03-29, under approval number K190023.

What company makes BTL-084?

BTL-084 is manufactured by BTL Industries, Inc..

What is the FDA product code for BTL-084?

The FDA product code for BTL-084 is PBX.

Other Devices by BTL Industries, Inc.

K162010HPM-6000U K160992HPM-6000 K161551TR-100 K152731XP1100 RF K163165AM-100 K163176Exilis XP II

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Related Devices (Code: PBX)

K162512truSculptCutera, Inc. K161458Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep CareIndiba USA, Inc. K161551TR-100BTL Industries, Inc. K161043Profound SystemSyneron Candela Corporation K160329InMode System MiniFX HandpieceInmode MD , Ltd. K161199EndyMed Contour HandpieceEndymed Medical, 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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