The following data is part of a premarket notification filed by Quantel Medical with the FDA for Optimus Fusion: Slt, Yag And Yag/slt.
| Device ID | K140336 |
| 510k Number | K140336 |
| Device Name: | OPTIMUS FUSION: SLT, YAG AND YAG/SLT |
| Classification | Laser, Ophthalmic |
| Applicant | QUANTEL MEDICAL 5 TIMBER LANE North Reading, MA 01864 |
| Contact | Maureen O'connell |
| Correspondent | Maureen O'connell QUANTEL MEDICAL 5 TIMBER LANE North Reading, MA 01864 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-10 |
| Decision Date | 2014-06-25 |
| Summary: | summary |