The following data is part of a premarket notification filed by W.c. Heraeus Gmbh with the FDA for Heracure Ls 500.
| Device ID | K875078 |
| 510k Number | K875078 |
| Device Name: | HERACURE LS 500 |
| Classification | Laser, Surgical, Gynecologic |
| Applicant | W.C. HERAEUS GMBH POSTFACH 1553 D-6450 HANAU 1 West Germany, DE |
| Contact | Wolfram Gorisch |
| Correspondent | Wolfram Gorisch W.C. HERAEUS GMBH POSTFACH 1553 D-6450 HANAU 1 West Germany, DE |
| Product Code | HHR |
| CFR Regulation Number | 884.4550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-29 |
| Decision Date | 1988-02-22 |