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Data / Medical devices / Bulgaria / BTL Industries JSC

BTL Industries JSC: FDA-registered device maker in Plovdiv, Bulgaria, 28 510(k) clearances

BTL Industries JSC is registered with the FDA (registration 3035374386) in Plovdiv, Bulgaria. It lists 14 device types. The FDA files 28 510(k) clearances under its listings, the newest dated August 23, 2026. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch BTL Industries JSC
FDA registration number
3035374386
Address
Vladaya 3, Plovdiv, Bulgaria, 4006
Owner or operator
BTL INDUSTRIES LTD (9071718)
Roles
Manufacturer
First device listed
May 31, 2009
Registered through
2027

Devices it lists

DeviceProduct codeClassRoleSource
Electromagnetic Stimulator, Pain ReliefQPL2Manufactureraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Manufactureraccessdata.fda.gov
Lamp, Infrared, Therapeutic HeatingILY2Manufactureraccessdata.fda.gov
Massager, Vacuum, Radio Frequency Induced HeatPBX2Manufactureraccessdata.fda.gov
Stimulator, Electrical, Non-Implantable, For IncontinenceKPI2Manufactureraccessdata.fda.gov
Stimulator, Muscle, PoweredIPF2Manufactureraccessdata.fda.gov
Stimulator, Muscle, Powered, DentalNUW2Manufactureraccessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle ConditioningNGX2Manufactureraccessdata.fda.gov
Stimulator, Transcutaneous Electrical, Aesthetic PurposesNFO2Manufactureraccessdata.fda.gov
System, Isokinetic Testing And EvaluationIKK2Manufactureraccessdata.fda.gov
Table, PoweredINQ1Manufactureraccessdata.fda.gov
Transcranial Magnetic Stimulation System For Obsessive-Compulsive DisorderQCI2Manufactureraccessdata.fda.gov
Transcranial Magnetic StimulatorOBP2Manufactureraccessdata.fda.gov
Vibrator, TherapeuticIRO1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 23, 2026K260691BTL-699OBPSubstantially EquivalentBTL Industries, Inc.accessdata.fda.gov
August 7, 2025K250309BTL-199QPLSubstantially EquivalentBTL Industries, Inc.accessdata.fda.gov
May 9, 2025K243290BTL-785MJNUWSubstantially EquivalentBTL Industries, Inc.accessdata.fda.gov
February 10, 2025K241516BTL-398KPISubstantially EquivalentBTL Industries, Inc.accessdata.fda.gov
December 13, 2024K242532BTL-785BNF-ENFOSubstantially EquivalentBTL Industries, Inc.accessdata.fda.gov
August 17, 2024K240234BTL-899MSIPFSubstantially EquivalentBTL Industries, Inc.accessdata.fda.gov
April 23, 2024K233849BTL-499GEISubstantially EquivalentBTL Industries, Inc.accessdata.fda.gov
March 28, 2024K233604BTL-785SGEISubstantially EquivalentBTL Industries, Inc.accessdata.fda.gov
September 21, 2023K230467BTL-899FGEISubstantially EquivalentBTL Industries, Inc.accessdata.fda.gov
May 31, 2023K222556BTL-785XGEISubstantially EquivalentBTL Industries, Inc.accessdata.fda.gov
March 7, 2022K211639BTL-785WGEISubstantially EquivalentBTL Industries, Inc.accessdata.fda.gov
March 4, 2022K212723BTL-995-rTMSOBPSubstantially EquivalentBTL Industries, Inc.accessdata.fda.gov
January 5, 2022K213344BTL-899AGEISubstantially EquivalentBTL Industries, Inc.accessdata.fda.gov
July 9, 2021K211107BTL-899 FPGEISubstantially EquivalentBTL Industries, Inc.accessdata.fda.gov
January 26, 2021K202199BTL-899STGEISubstantially EquivalentBtlaccessdata.fda.gov
January 6, 2021K200382BTL-703-2NGXSubstantially EquivalentBtlaccessdata.fda.gov
August 21, 2020K193201BTL-785FGEISubstantially EquivalentBtlaccessdata.fda.gov
December 5, 2019K192224BTL-899GEISubstantially EquivalentBtlaccessdata.fda.gov
July 5, 2019K190456BTL 799-2LNGXSubstantially EquivalentBTL Industries, Inc.accessdata.fda.gov
March 29, 2019K190023BTL-084PBXSubstantially EquivalentBTL Industries, Inc.accessdata.fda.gov
November 14, 2018K181497HPM-6000UFKPISubstantially EquivalentBTL Industries, Inc.accessdata.fda.gov
January 12, 2017K163176Exilis XP IIPBXSubstantially EquivalentBTL Industries, Inc.accessdata.fda.gov
September 13, 2016K161551TR-100PBXSubstantially EquivalentBTL Industries, Inc.accessdata.fda.gov
July 20, 2016K152731XP1100 RFGEISubstantially EquivalentBTL Industries, Inc.accessdata.fda.gov
September 16, 2015K150720XP3000PBXSubstantially EquivalentBTL Industries, Inc.accessdata.fda.gov
June 11, 2015K143559XP1000 RFGEISubstantially EquivalentBTL Industries, Inc.accessdata.fda.gov
April 8, 2013K122966XP200GEISubstantially EquivalentBtl Industries, Ltd.accessdata.fda.gov
November 25, 2009K092191EXILIS, MODEL 5000GEISubstantially EquivalentBtl Industries, Ltd.accessdata.fda.gov

Compare with other makers

Updated August 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.