The following data is part of a premarket notification filed by Laser Media with the FDA for Nd:yag Laser Single Use Fiber Delivery System.
| Device ID | K860063 |
| 510k Number | K860063 |
| Device Name: | ND:YAG LASER SINGLE USE FIBER DELIVERY SYSTEM |
| Classification | Laser For Gastro-urology Use |
| 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 | LNK |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-06 |
| Decision Date | 1986-02-05 |