BTL Industries, Inc.
Medical device manufacturer in Marlborough, MA.
46510(k) clearances
0PMA approvals
0recalls
Device types
- GEI Electrosurgical, Cutting & Coagulation &… 14
- PBX Massager, Vacuum, Radio Frequency Induced… 5
- NGX Stimulator, Muscle, Powered, For Muscle… 4
- IMJ Diathermy, Shortwave, For Use In Applying… 3
- IPF Stimulator, Muscle, Powered 3
- KPI Stimulator, Electrical, Non-Implantable… 3
- GEX Powered Laser Surgical Instrument 2
- OBP Transcranial Magnetic Stimulator 2
- NFO Stimulator, Transcutaneous Electrical… 2
- QPL Electromagnetic Stimulator, Pain Relief 1
- NUW Stimulator, Muscle, Powered, Dental 1
- QCI Transcranial Magnetic Stimulation System… 1
- ISA Massager, Therapeutic, Electric 1
- IMG Stimulator, Ultrasound And Muscle, For Use… 1
- ONF Powered Light Based Non-Laser Surgical… 1
- OLI Fat Reducing Low Level Laser 1
- MWJ Electrocardiograph, Ambulatory (Without… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K260691 | BTL-699OBP · Traditional | 08/23/2026SE |
| K252963 | BTL-899TTIMJ · Traditional | 06/12/2026SE |
| K253750 | BTL-785NEHGEI · Traditional | 03/17/2026SE |
| K252561 | BTL-754FFGEX · Traditional | 02/18/2026SE |
| K250309 | BTL-199QPL · Traditional | 08/07/2025SE |
| K243290 | BTL-785MJNUW · Traditional | 05/09/2025SE |
| K241516 | BTL-398KPI · Traditional | 02/10/2025SE |
| K241270 | BTL-754GEX · Traditional | 01/30/2025SE |
| K242532 | BTL-785BNF-ENFO · Traditional | 12/13/2024SE |
| K240234 | BTL-899MSIPF · Traditional | 08/17/2024SE |
| K233849 | BTL-499GEI · Traditional | 04/23/2024SE |
| K233604 | BTL-785SGEI · Traditional | 03/28/2024SE |
| K230657 | BTL-99-OCQCI · Traditional | 02/01/2024SE |
| K232937 | BTL-899MIPF · Traditional | 12/26/2023SE |
| K230467 | BTL-899FGEI · Traditional | 09/21/2023SE |
| K232172 | BTL-785BNF HandpieceNFO · Traditional | 09/18/2023SE |
| K222556 | BTL-785XGEI · Traditional | 05/31/2023SE |
| K221865 | BTL-094ISA · Traditional | 04/14/2023SE |
| K211639 | BTL-785WGEI · Traditional | 03/07/2022SE |
| K212723 | BTL-995-rTMSOBP · Traditional | 03/04/2022SE |
| K213344 | BTL-899AGEI · Traditional | 01/05/2022SE |
| K211107 | BTL-899 FPGEI · Traditional | 07/09/2021SE |
| K190456 | BTL 799-2LNGX · Traditional | 07/05/2019SE |
| K190023 | BTL-084PBX · Traditional | 03/29/2019SE |
| K182363 | BTL-703IMJ · Traditional | 01/24/2019SE |
| K180359 | BTL-FR2000GEI · Traditional | 12/13/2018SE |
| K181497 | HPM-6000UFKPI · Traditional | 11/14/2018SE |
| K182106 | BTL 799-2TNGX · Traditional | 10/23/2018SE |
| K180813 | BTL 799-2NGX · Traditional | 06/14/2018SE |
| K163165 | AM-100NGX · Traditional | 02/16/2017SE |
| K163176 | Exilis XP IIPBX · Traditional | 01/12/2017SE |
| K162010 | HPM-6000UKPI · Traditional | 12/13/2016SE |
| K160992 | HPM-6000IPF · Traditional | 10/21/2016SE |
| K161551 | TR-100PBX · Traditional | 09/13/2016SE |
| K152731 | XP1100 RFGEI · Traditional | 07/20/2016SE |
| K150353 | BTL-4000IMG · Traditional | 11/13/2015SE |
| K150720 | XP3000PBX · Traditional | 09/16/2015SE |
| K143559 | XP1000 RFGEI · Traditional | 06/11/2015SE |
| K150051 | ExiliteONF · Traditional | 04/08/2015SE |
| K143109 | XP300GEI · Special | 03/06/2015SE |
| K143040 | Exilis XPPBX · Traditional | 01/15/2015SE |
| K134040 | BTL-9000; BTL-9000 Radiofrequency ModuleOLI · Traditional | 09/10/2014SE |
| K122966 | XP200GEI · Traditional | 04/08/2013SE |
| K120093 | BTL EliteIMJ · Traditional | 10/05/2012SE |
| K100310 | BTL-08 ECG Recorder Model BTL-08 ECG LC Plus, BTL-08 ECG LT PlusMWJ · Traditional | 10/13/2010SE |
| K092191 | Exilis, Model 5000GEI · Traditional | 11/25/2009SE |