The following data is part of a premarket notification filed by Laser Media with the FDA for Fiberlase 100 Medical Laser Sys/nd:yag Menorrhagia.
| Device ID | K862444 |
| 510k Number | K862444 |
| Device Name: | FIBERLASE 100 MEDICAL LASER SYS/ND:YAG MENORRHAGIA |
| Classification | Laser, Surgical, Gynecologic |
| Applicant | LASER MEDIA 77 ARKAY DR. Hauppauge, NY 11788 |
| Contact | Robert A Kaplan |
| Correspondent | Robert A Kaplan LASER MEDIA 77 ARKAY DR. Hauppauge, NY 11788 |
| Product Code | HHR |
| CFR Regulation Number | 884.4550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-26 |
| Decision Date | 1986-09-25 |