FDA.reportPublic FDA data

Multi-modality hyperthermia system

Definition
A mains electricity (AC-powered) device assembly designed for controlled heating (i.e., temperatures above 43° Celsius) of the body using multiple energy sources, for the treatment of malignant or benign tumours, or other disease conditions. It includes a patient-end applicator, software, and a multi-modality generator(s)/control unit. It is intended to achieve whole-body and localized heating of tissues using two or more energy sources [e.g., ultrasound, radio-frequency (RF), microwave, circulating heated fluid] through either externally-mounted components, or from catheter- or probe-type applicators inserted endoscopically or surgically.
GUDID devices
40
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B108284AP01EMTENUS0100EMTONE applicatorBTL INDUSTRIES LIMITEDBTL-284-012019-08-16
B108784POEMTENUS0100EMTONEBTL INDUSTRIES LIMITEDEMTONE2019-08-16
B108899PO11C1ENUS0150EMSCULPT NEOBTL INDUSTRIES LIMITEDEMSCULPT NEO2024-09-23
B108899AP2C2MUS20Small applicatorBTL INDUSTRIES LIMITED899-AP-C-22023-12-08
B108899AP2C45MUS10Edge applicatorBTL INDUSTRIES LIMITEDEdge applicator2023-12-08
B108899APC1ENUS0140Large applicatorBTL INDUSTRIES LIMITED899-AP-C-12023-12-08
B108899PO11C1ENUS0140EMSCULPT NEOBTL INDUSTRIES LIMITEDEMSCULPT NEO2023-12-08
B108785PO8MUS00BTL-785FBTL INDUSTRIES LIMITEDBTL-785F2023-12-01
B108785PO9MUS00BTL-785FBTL INDUSTRIES LIMITEDBTL-785F2023-12-01
B108785PO2MUS00BTL-785FBTL INDUSTRIES LIMITEDBTL-785F2023-10-20
B108785APMMUS10EMFACE controllerBTL INDUSTRIES LIMITEDBTL-785-72023-06-28
B108785PO6MUS10BTL-785LBTL INDUSTRIES LIMITEDBTL-785L2023-06-28
B108785APFMUS10EXION Fractional RF applicatorBTL INDUSTRIES LIMITEDBTL-785-42023-05-02
B108785APLMUS10EXION Body applicatorBTL INDUSTRIES LIMITEDBTL-785-12023-05-02
B108785APSMUS10EXION Face applicatorBTL INDUSTRIES LIMITEDBTL-785-22023-05-02
B108785PO6MUS00BTL-785LBTL INDUSTRIES LIMITEDBTL-785L2023-05-02
B108785PO7MUS00BTL-785FBTL INDUSTRIES LIMITEDBTL-785F2023-05-02
B108785APMMUS00EMFACE controllerBTL INDUSTRIES LIMITEDBTL-785-72022-08-08
B108785PO5MUS00BTL-785FBTL INDUSTRIES LIMITEDBTL-785F2022-07-18
B108899AP2C2MUS10Small applicatorBTL INDUSTRIES LIMITED899-AP-C-22022-07-18
B108899AP2C45MUS00Edge applicatorBTL INDUSTRIES LIMITEDEdge applicator2022-07-18
B108899APC1ENUS0130Large applicatorBTL INDUSTRIES LIMITED899-AP-C-12022-07-18
B108899PO11C1ENUS0130EMSCULPT NEOBTL INDUSTRIES LIMITEDEMSCULPT NEO2022-07-18
B108785TIPV24MUS00EMFEMME V24 tipBTL INDUSTRIES LIMITEDEMFEMME V24 tip2022-03-04
B108785TIPV30MUS00EMFEMME V30 tipBTL INDUSTRIES LIMITEDEMFEMME V30 tip2022-03-04
B108785TIPVMUS00EMFEMME V tipBTL INDUSTRIES LIMITEDEMFEMME V tip2022-03-04
B108785APFMUS00FRACTIONAL applicatorBTL INDUSTRIES LIMITEDFRACTIONAL applicator2021-12-22
B108785APLMUS00LARGE applicatorBTL INDUSTRIES LIMITEDLARGE applicator2021-12-22
B108785APSMUS00SMALL applicatorBTL INDUSTRIES LIMITEDSMALL applicator2021-12-22
B108785APVMUS00EMFEMME applicatorBTL INDUSTRIES LIMITEDEMFEMME applicator2021-12-22
B108785POFMUS00BTL-785FBTL INDUSTRIES LIMITEDBTL-785F2021-12-15
B108899APC1ENUS0120Large applicatorBTL INDUSTRIES LIMITED899-AP-C-12021-08-25
B108899PO11C1ENUS0120EMSCULPT NEOBTL INDUSTRIES LIMITEDEMSCULPT NEO2021-08-25
B108899APC1ENUS0110Large applicatorBTL INDUSTRIES LIMITED899-AP-C-12021-03-08
B108899PO11C1ENUS0110EMSCULPT NEOBTL INDUSTRIES LIMITEDEMSCULPT NEO2021-03-08
B108899APC1ENUS0100Large applicatorBTL INDUSTRIES LIMITED899-AP-C-12020-03-02
B108899PO11C1ENUS0100EMSCULPT NEOBTL INDUSTRIES LIMITEDEMSCULPT NEO2020-03-02
B108703POENUS0100BTL-703BTL INDUSTRIES LIMITEDBTL-7032019-04-16
B108284AP01ENUS0100BTL Unison applicatorBTL INDUSTRIES LIMITEDBTL-284-012018-10-10
B108784POENUS0100BTL UnisonBTL INDUSTRIES LIMITEDBTL Unison2018-10-10