The following data is part of a premarket notification filed by Daavlin Distributing Co. with the FDA for Plasmaluxls.
| Device ID | K100628 |
| 510k Number | K100628 |
| Device Name: | PLASMALUXLS |
| Classification | Powered Light Based Non-laser Surgical Instrument |
| Applicant | DAAVLIN DISTRIBUTING CO. 205 WEST BEMENT ST. Bryan, OH 43506 |
| Contact | Michele Thiel |
| Correspondent | Michele Thiel DAAVLIN DISTRIBUTING CO. 205 WEST BEMENT ST. Bryan, OH 43506 |
| Product Code | ONE |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-05 |
| Decision Date | 2010-11-24 |
| Summary: | summary |