The following data is part of a premarket notification filed by Lutronic Corporation with the FDA for Spectra Sp Ii, Spectra Denta Ii.
| Device ID | K091320 |
| 510k Number | K091320 |
| Device Name: | SPECTRA SP II, SPECTRA DENTA II |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUTRONIC CORPORATION 5 TIMBER LANE North Reading, MA 01864 |
| Contact | Maureen O'connell |
| Correspondent | Maureen O'connell LUTRONIC CORPORATION 5 TIMBER LANE North Reading, MA 01864 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-05 |
| Decision Date | 2009-08-19 |
| Summary: | summary |