The following data is part of a premarket notification filed by Cooper Lasersonics, Inc. with the FDA for Laser For Genitourinary Applic. 4000.
| Device ID | K843240 |
| 510k Number | K843240 |
| Device Name: | LASER FOR GENITOURINARY APPLIC. 4000 |
| Classification | Laser For Gastro-urology Use |
| Applicant | COOPER LASERSONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LNK |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-22 |
| Decision Date | 1984-10-02 |