The following data is part of a premarket notification filed by Quantel Medical with the FDA for Solutis.
| Device ID | K130933 |
| 510k Number | K130933 |
| Device Name: | SOLUTIS |
| 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 | 2013-04-04 |
| Decision Date | 2013-08-02 |
| Summary: | summary |