The following data is part of a premarket notification filed by Lutronic Corporation with the FDA for Lutronic Corporation Eco2 Plus, Denta Iii And Iii+ And Sp Iii Laser Systems.
| Device ID | K100610 |
| 510k Number | K100610 |
| Device Name: | LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS |
| Classification | Powered Laser Surgical Instrument With Microbeam\fractional Output |
| 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 | ONG |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-03 |
| Decision Date | 2011-01-20 |
| Summary: | summary |