Marlborough, MA, US · 21 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General, Plastic Surgery | 8 | 2026-03-17 |
| GEX | Powered Laser Surgical Instrument | Class II | General, Plastic Surgery | 2 | 2026-02-18 |
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | Class II | Neurology | 2 | 2024-12-13 |
| IPF | Stimulator, Muscle, Powered | Class II | Physical Medicine | 2 | 2024-08-17 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | Class II | Physical Medicine | 1 | 2026-06-12 |
| QPL | Electromagnetic Stimulator, Pain Relief | Class II | Neurology | 1 | 2025-08-07 |
| NUW | Stimulator, Muscle, Powered, Dental | Class II | Physical Medicine | 1 | 2025-05-09 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | Class II | Gastroenterology, Urology | 1 | 2025-02-10 |
| QCI | Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder | Class II | Neurology | 1 | 2024-02-01 |
| ISA | Massager, Therapeutic, Electric | Class I | Physical Medicine | 1 | 2023-04-14 |
| OBP | Transcranial Magnetic Stimulator | Class II | Neurology | 1 | 2022-03-04 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-06-12 | K252963 | BTL-899TT | IMJ | Class II | Physical Medicine |
| 2026-03-17 | K253750 | BTL-785NEH | GEI | Class II | General, Plastic Surgery |
| 2026-02-18 | K252561 | BTL-754FF | GEX | Class II | General, Plastic Surgery |
| 2025-08-07 | K250309 | BTL-199 | QPL | Class II | Neurology |
| 2025-05-09 | K243290 | BTL-785MJ | NUW | Class II | Physical Medicine |
| 2025-02-10 | K241516 | BTL-398 | KPI | Class II | Gastroenterology, Urology |
| 2025-01-30 | K241270 | BTL-754 | GEX | Class II | General, Plastic Surgery |
| 2024-12-13 | K242532 | BTL-785BNF-E | NFO | Class II | Neurology |
| 2024-08-17 | K240234 | BTL-899MS | IPF | Class II | Physical Medicine |
| 2024-04-23 | K233849 | BTL-499 | GEI | Class II | General, Plastic Surgery |
| 2024-03-28 | K233604 | BTL-785S | GEI | Class II | General, Plastic Surgery |
| 2024-02-01 | K230657 | BTL-99-OC | QCI | Class II | Neurology |
| 2023-12-26 | K232937 | BTL-899M | IPF | Class II | Physical Medicine |
| 2023-09-21 | K230467 | BTL-899F | GEI | Class II | General, Plastic Surgery |
| 2023-09-18 | K232172 | BTL-785BNF Handpiece | NFO | Class II | Neurology |
| 2023-05-31 | K222556 | BTL-785X | GEI | Class II | General, Plastic Surgery |
| 2023-04-14 | K221865 | BTL-094 | ISA | Class I | Physical Medicine |
| 2022-03-07 | K211639 | BTL-785W | GEI | Class II | General, Plastic Surgery |
| 2022-03-04 | K212723 | BTL-995-rTMS | OBP | Class II | Neurology |
| 2022-01-05 | K213344 | BTL-899A | GEI | Class II | General, Plastic Surgery |
| 2021-07-09 | K211107 | BTL-899 FP | GEI | Class II | General, Plastic Surgery |