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BTL Industries, Inc.

US

Last updated May 24, 2026

Part of BTL Industries Limited

What BTL Industries, Inc. makes

BTL Industries, Inc. manufactures medical devices including multi-modality hyperthermia systems, deep-tissue electromagnetic stimulation systems, hyperthermia system gantries, transcutaneous electrical stimulation electrodes, magnetic neural stimulation systems, multi-modality skin surface treatment systems, hand-held electric massagers, and electrosurgical system generators. Specific devices include EMTONE, EMSCULPT NEO, BTL-785L, and various applicators and handpieces.

The company's portfolio includes Class I and Class II devices listed in the FDA 510(k) and FDA UDI registries. BTL Industries, Inc. is based in the US.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What medical devices does BTL Industries, Inc. manufacture?

BTL Industries, Inc. produces various medical devices including multi-modality hyperthermia systems, deep-tissue electromagnetic stimulation systems, hyperthermia system gantries, transcutaneous electrical stimulation electrodes, magnetic neural stimulation systems, multi-modality skin surface treatment systems, hand-held electric massagers, and electrosurgical system generators. Specific examples include EMTONE, EMSCULPT NEO, BTL-785L, and various applicators and handpieces.

Where is BTL Industries, Inc. based?

BTL Industries, Inc. is based in the United States. The company operates from its headquarters located in the US, where it designs, manufactures, and distributes its medical devices to various markets.

Which regulatory registries list BTL Industries, Inc.'s devices?

BTL Industries, Inc.'s devices are listed in the FDA 510(k) and FDA UDI registries. These registries track medical devices that have been notified to the FDA, with 510(k) indicating pre-market notification and UDI providing unique device identification for traceability.

How are BTL Industries, Inc.'s devices classified?

BTL Industries, Inc.'s medical devices are classified as Class I and Class II. Class I devices pose minimal risk and are subject to general controls, while Class II devices require special controls in addition to general controls to ensure safety and effectiveness.

AI-generated from registry data and not verified by a human reviewer.

Information

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US
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Catalogue (137)

Page 3 of 3
DeviceModel / ReferenceRegistriesClassStatus
Btl-4000 K150353
FDA 510(k)
Class IIActive
Btl-899f K230467
FDA 510(k)
Class IIActive
Btl-99-Oc K230657
FDA 510(k)
Class IIActive
Xp1100 Rf K152731
FDA 510(k)
Class IIActive
Btl-899a K213344
FDA 510(k)
Class IIActive
Hpm-6000uf K181497
FDA 510(k)
Class IIActive
Xp3000 K150720
FDA 510(k)
Class IIActive
Btl-754ff K252561
FDA 510(k)
Class IIActive
Btl-785bnf-E K242532
FDA 510(k)
Class IIActive
Xp1000 Rf K143559
FDA 510(k)
Class IIActive
Btl-084 K190023
FDA 510(k)
Class IIActive
Btl-785s K233604
FDA 510(k)
Class IIActive
Btl-785w K211639
FDA 510(k)
Class IIActive
Btl-785x K222556
FDA 510(k)
Class IIActive
Exilis, Model 5000 K092191
FDA 510(k)
Class IIActive
Btl-785mj K243290
FDA 510(k)
Class IIActive
Am-100 K163165
FDA 510(k)
Class IIActive
BTL-785BNF Handpiece K232172
FDA 510(k)
Class IIActive
Btl-199 K250309
FDA 510(k)
Class IIActive
Btl-703 K182363
FDA 510(k)
Class IIActive
Exilite K150051
FDA 510(k)
Class IIActive
Xp300 K143109
FDA 510(k)
Class IIActive
Btl-094 K221865
FDA 510(k)
Class IActive
Btl-899ms K240234
FDA 510(k)
Class IIActive
Btl-785neh K253750
FDA 510(k)
Class IIActive
Tr-100 K161551
FDA 510(k)
Class IIActive
Btl-754 K241270
FDA 510(k)
Class IIActive
Btl-899 Fp K211107
FDA 510(k)
Class IIActive
Btl-9000; Btl-9000 Radiofrequency Module K134040
FDA 510(k)
Class IIActive
Btp(tm) Centraline(tm) Suit K914615
FDA 510(k)
Class IActive
Xp200 K122966
FDA 510(k)
Class IIActive
Hpm-6000u K162010
FDA 510(k)
Class IIActive
Btl 799-2l K190456
FDA 510(k)
Class IIActive
Btl-398 K241516
FDA 510(k)
Class IIActive
Btl 799-2t K182106
FDA 510(k)
Class IIActive
Btl 799-2 K180813
FDA 510(k)
Class IIActive
BTL-995-rTMS K212723
FDA 510(k)
Class IIActive

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