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Sign in to claim this brandWhat 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.
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- US
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Catalogue (137)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Edge applicator | Edge applicator | FDA UDI | Class II | Active |
| LARGE applicator | LARGE applicator | FDA UDI | Class II | Active |
| Small applicator | 899-AP-M-2 | FDA UDI | Class II | Active |
| Hpm-6000u | HPM-6000U | FDA UDI | Class II | Active |
| BTL Chair Applicator | BTL Chair Applicator | FDA UDI | Class II | Active |
| Ls-6000 | LS-6000 | FDA UDI | Class II | Active |
| Btl-785f | BTL-785F | FDA UDI | Class II | Active |
| Exilis large applicator | 215/1 | FDA UDI | Class II | Active |
| Btl-785l | BTL-785L | FDA UDI | Class II | Active |
| EXION Face applicator | BTL-785-2 | FDA UDI | Class II | Active |
| Btl Emsculpt | BTL EMSCULPT | FDA UDI | Class II | Active |
| Vanquish Applicator | 713/1 | FDA UDI | Class II | Active |
| Btl-299-6 | BTL-299-6 | FDA UDI | Class II | Active |
| EMFACE controller | BTL-785-7 | FDA UDI | Class II | Active |
| EXION Fractional RF applicator | BTL-785-4 | FDA UDI | Class II | Active |
| XP 2 applicator | 215-7 | FDA UDI | Class II | Active |
| SMALL applicator | SMALL applicator | FDA UDI | Class II | Active |
| Emsculpt Neo | EMSCULPT NEO | FDA UDI | Class II | Active |
| Btl Emsella | BTL EMSELLA | FDA UDI | Class II | Active |
| BTL Unison | BTL Unison | FDA UDI | Class II | Active |
| Exilis | BTL Exilis Ultra | FDA UDI | Class II | Active |
| BTL Chair Applicator | 899-AP-M-3 | FDA UDI | Class II | Active |
| Btl-785f | BTL-785F | FDA UDI | Class II | Active |
| BTL Cellutone handpiece | BTL Cellutone handpiece | FDA UDI | Class II | Active |
| Btl-299-6 | BTL-299-6 | FDA UDI | Class II | Active |
| FRACTIONAL applicator | FRACTIONAL applicator | FDA UDI | Class II | Active |
| Edge applicator | Edge applicator | FDA UDI | Class II | Active |
| BTL Unison applicator | BTL-284-01 | FDA UDI | Class II | Active |
| Exilis small applicator | 215/2 | FDA UDI | Class II | Active |
| EMFEMME V tip | EMFEMME V tip | FDA UDI | Class II | Active |
| Btl Emsella | BTL EMSELLA | FDA UDI | Class II | Active |
| EMFACE controller | BTL-785-7 | FDA UDI | Class II | Active |
| Btl-785f | BTL-785F | FDA UDI | Class II | Active |
| Emsculpt Neo | EMSCULPT NEO | FDA UDI | Class II | Active |
| Headrest | Headrest | FDA UDI | Class II | Active |
| Btl-299-6 | BTL-299-6 | FDA UDI | Class II | Active |
| EMFEMME V24 tip | EMFEMME V24 tip | FDA UDI | Class II | Active |
| BTL Exilite handpiece | BTL Exilite handpiece | FDA UDI | Class II | Active |
| Btl-785f | BTL-785F | FDA UDI | Class II | Active |
| Large applicator | 899-AP-C-1 | FDA UDI | Class II | Active |
| BTL Cellutone handpiece | BTL Cellutone handpiece | FDA UDI | Class I | Active |
| Btl-585 | BTL-585 | FDA UDI | Class II | Active |
| BTL Cellutone | BTL Cellutone | FDA UDI | Class II | Active |
| Btl-499 | K233849 | FDA 510(k) | Class II | Active |
| Exilis XP | K143040 | FDA 510(k) | Class II | Active |
| Btl-899m | K232937 | FDA 510(k) | Class II | Active |
| Hpm-6000 | K160992 | FDA 510(k) | Class II | Active |
| Exilis XP II | K163176 | FDA 510(k) | Class II | Active |
| Btl-Fr2000 | K180359 | FDA 510(k) | Class II | Active |
| Btl-08 Ecg Recorder Model Btl-08 Ecg Lc Plus, Btl-08 Ecg Lt Plus | K100310 | FDA 510(k) | Class II | Active |
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