Medical Device Manufacturer · US , Malborough , MA

BTL Industries, Inc.

40 submissions · 40 cleared · Since 2010
40
Total
40
Cleared
0
Denied

BTL Industries, Inc. — FDA 510(k) Submissions

BTL Industries, Inc. has submitted 40 FDA 510(k) premarket notifications since 2010, of which 40 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrosurgical, Cutting & Coagulation & Accessories, Massager, Vacuum, Radio Frequency Induced Heat, Stimulator, Muscle, Powered, For Muscle Conditioning, Stimulator, Muscle, Powered, Stimulator, Electrical, Non-implantable, For Incontinence . Use the specialty filter in the sidebar to narrow results.

40 devices
1–25 of 40
BTL-754FF
K252561 · GEX Powered Laser Surgical... · General & Plastic Surgery
Feb 2026 189d
BTL-199
K250309 · QPL Electromagnetic... · Physical Medicine
Aug 2025 185d
BTL-785MJ
K243290 · NUW Stimulator, Muscle,... · Dental
May 2025 203d
BTL-398
K241516 · KPI Stimulator, Electrical,... · Gastroenterology & Urology
Feb 2025 257d
BTL-754
K241270 · GEX Powered Laser Surgical... · General & Plastic Surgery
Jan 2025 269d
BTL-785BNF-E
K242532 · NFO Stimulator,... · Neurology
Dec 2024 109d
BTL-899MS
K240234 · IPF Stimulator, Muscle, Powered · Physical Medicine
Aug 2024 201d
BTL-499
K233849 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Apr 2024 140d
BTL-785S
K233604 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Mar 2024 140d
BTL-99-OC
K230657 · QCI Transcranial Magnetic... · Neurology
Feb 2024 329d
BTL-899M
K232937 · IPF Stimulator, Muscle, Powered · Physical Medicine
Dec 2023 97d
BTL-899F
K230467 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Sep 2023 212d
BTL-785BNF Handpiece
K232172 · NFO Stimulator,... · Neurology
Sep 2023 59d
BTL-785X
K222556 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
May 2023 281d
BTL-094
K221865 · ISA Massager, Therapeutic,... · Physical Medicine
Apr 2023 291d
BTL-785W
K211639 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Mar 2022 284d
BTL-995-rTMS
K212723 · OBP Transcranial Magnetic... · Neurology
Mar 2022 189d
BTL-899A
K213344 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jan 2022 90d
BTL-899 FP
K211107 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jul 2021 86d
BTL 799-2L
K190456 · NGX Stimulator, Muscle,... · Physical Medicine
Jul 2019 130d
BTL-084
K190023 · PBX Massager, Vacuum, Radio... · General & Plastic Surgery
Mar 2019 84d
BTL-703
K182363 · IMJ Diathermy, Shortwave, For... · Physical Medicine
Jan 2019 147d
BTL-FR2000
K180359 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 2018 307d
HPM-6000UF
K181497 · KPI Stimulator, Electrical,... · Gastroenterology & Urology
Nov 2018 160d
BTL 799-2T
K182106 · NGX Stimulator, Muscle,... · Physical Medicine
Oct 2018 81d
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