The following data is part of a premarket notification filed by Btl Industries, Inc. with the FDA for Exilis Xp Ii.
| Device ID | K163176 |
| 510k Number | K163176 |
| Device Name: | Exilis XP II |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | BTL Industries, Inc. 47 Loring Drive Framingham, MA 01702 |
| Contact | David Chmel |
| Correspondent | David Chmel BTL Industries, Inc. 47 Loring Drive Framingham, MA 01702 |
| Product Code | PBX |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-14 |
| Decision Date | 2017-01-12 |
| Summary: | summary |