The following data is part of a premarket notification filed by Btl Industries Ltd with the FDA for Btl-9000; Btl-9000 Radiofrequency Module.
| Device ID | K134040 |
| 510k Number | K134040 |
| Device Name: | BTL-9000; BTL-9000 RADIOFREQUENCY MODULE |
| Classification | Fat Reducing Low Level Laser |
| Applicant | BTL INDUSTRIES LTD 16 APPLETON STREET Waltham, MA 02453 |
| Contact | Michail M Pankratov |
| Correspondent | Michail M Pankratov BTL INDUSTRIES LTD 16 APPLETON STREET Waltham, MA 02453 |
| Product Code | OLI |
| CFR Regulation Number | 878.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-31 |
| Decision Date | 2014-09-10 |
| Summary: | summary |