FDA.reportPublic FDA data

FRACTIONAL applicator

Primary DI
B108785APFMUS00
Brand
FRACTIONAL applicator
Company
BTL INDUSTRIES LIMITED
Model
FRACTIONAL applicator
Published
2021-12-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B108785APFMUS00PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality hyperthermia systemA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
733532951
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B108660POMUS00R-GAITR-GAIT2026-03-19
B108899PO11C1ENUS0150EMSCULPT NEOEMSCULPT NEO2024-09-23
B108043POEMVMUS00EMVITALEMVITAL2025-11-19
B108451APHFAMUS00EMVITAL Hands-Free ApplicatorEMVITAL Hands-Free Applicator2025-11-19
B108785APMMUS10EMFACE controllerBTL-785-72023-06-28
B108699PO3M2MUS00BTL-699 EXOMINDBTL-699 EXOMIND2025-04-04
B108699BELTMEU00BeltBelt2024-11-06
B108699HEADRESTMEU00HeadrestHeadrest2024-11-06
B108699APM2MUS00EXOMIND applicatorBTL-699-AP-M-22024-08-28
B108699PO2M2MUS00EXOMINDEXOMIND2024-08-28
B108043PO30WMUS00LS-6000LS-60002024-03-22
B108451POSCAEL2MUS00Scanning System for LS-6000Scanning System for LS-60002024-03-22
B108A299AP13ENUS1020BTL Chair ApplicatorBTL Chair Applicator2019-02-25
B108D099PO130ENUS1030BTL EMSELLABTL EMSELLA2019-02-25
B108899AP2C2MUS20Small applicator899-AP-C-22023-12-08
B108899AP2C45MUS10Edge applicatorEdge applicator2023-12-08
B108899APC1ENUS0140Large applicator899-AP-C-12023-12-08
B108899PO11C1ENUS0140EMSCULPT NEOEMSCULPT NEO2023-12-08
B108785PO8MUS00BTL-785FBTL-785F2023-12-01
B108785PO9MUS00BTL-785FBTL-785F2023-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776408718MillenniumAvalign Technologies, Inc.GEI2026-08-03
00190776422677MillenniumAvalign Technologies, Inc.GEI2026-08-03
00190776422820MillenniumAvalign Technologies, Inc.GEI2026-08-03
B382SD5657815600Surgical DirectSurgical Direct, Inc.GEI2026-08-03
00190776407445MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422332MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422516MillenniumAvalign Technologies, Inc.GEI2026-07-31
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-29
00198506093562ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-29
07613327688849MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688856MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688979MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688986MalisSTRYKER CORPORATIONGEI2026-07-29
08800020110688INTRAGen HandpieceJeisys Medical Inc.GEI2026-07-29
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP81Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP82Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP83Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP84Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP85Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP89Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
00190776407285MillenniumAvalign Technologies, Inc.GEI2026-07-28
00190776407292MillenniumAvalign Technologies, Inc.GEI2026-07-28
00198506092770ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092886ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092893ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092909ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092916ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092954ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092961ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28