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 |