The following data is part of a premarket notification filed by Medical Laser, Inc. with the FDA for Medilase System 2010l Laser Lithotriptor.
| Device ID | K895837 |
| 510k Number | K895837 |
| Device Name: | MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MEDICAL LASER, INC. 2605 FERNBROOK LN. Minneapolis, MN 55447 |
| Contact | Sharon Karr |
| Correspondent | Sharon Karr MEDICAL LASER, INC. 2605 FERNBROOK LN. Minneapolis, MN 55447 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-03 |
| Decision Date | 1989-12-14 |