The following data is part of a premarket notification filed by Endo Lase, Inc. with the FDA for Medilas Laser.
| Device ID | K833557 |
| 510k Number | K833557 |
| Device Name: | MEDILAS LASER |
| Classification | Laser For Gastro-urology Use |
| Applicant | ENDO LASE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LNK |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-07 |
| Decision Date | 1984-02-07 |