The following data is part of a premarket notification filed by Medical Laser Solutions Llc. with the FDA for Umeco Optima Multiline Laser System.
| Device ID | K000693 |
| 510k Number | K000693 |
| Device Name: | UMECO OPTIMA MULTILINE LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MEDICAL LASER SOLUTIONS LLC. 36 MYSTIC ST. Charlestown, MA 02129 |
| Contact | Iain D Miller |
| Correspondent | Iain D Miller MEDICAL LASER SOLUTIONS LLC. 36 MYSTIC ST. Charlestown, MA 02129 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-01 |
| Decision Date | 2000-05-16 |