The following data is part of a premarket notification filed by Laser Media with the FDA for Fiberlase 100 Nd: Yag Medical Laser System.
| Device ID | K855197 |
| 510k Number | K855197 |
| Device Name: | FIBERLASE 100 ND: YAG MEDICAL LASER SYSTEM |
| Classification | Laser For Gastro-urology Use |
| Applicant | LASER MEDIA 77 ARKAY DR. Hauppauge, NY 11788 |
| Contact | Robert Kaplan |
| Correspondent | Robert Kaplan LASER MEDIA 77 ARKAY DR. Hauppauge, NY 11788 |
| Product Code | LNK |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-26 |
| Decision Date | 1986-01-21 |