The following data is part of a premarket notification filed by Quantel S.a. with the FDA for Prolite Iii Tower And Pr And Hr Handpiece.
| Device ID | K081095 |
| 510k Number | K081095 |
| Device Name: | PROLITE III TOWER AND PR AND HR HANDPIECE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | QUANTEL S.A. 601 HAGGERTY LANE Bozeman, MT 59715 |
| Contact | Michael Johnson |
| Correspondent | Michael Johnson QUANTEL S.A. 601 HAGGERTY LANE Bozeman, MT 59715 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-17 |
| Decision Date | 2008-12-12 |
| Summary: | summary |