The following data is part of a premarket notification filed by Btl Industries, Inc. with the FDA for Exilite.
| Device ID | K150051 |
| 510k Number | K150051 |
| Device Name: | Exilite |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | BTL Industries, Inc. 47 Loring Drive Framingham, MA 01702 |
| Contact | Jan Zarsky |
| Correspondent | Jan Zarsky BTL Industries, Inc. 47 Loring Drive Framingham, MA 01702 |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-12 |
| Decision Date | 2015-04-08 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EXILITE 86899421 5498251 Live/Registered |
BTL INDUSTRIES, INC. 2016-02-05 |
![]() EXILITE 85307111 not registered Dead/Abandoned |
BTL Industries, Inc. 2011-04-28 |