The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Optilase Yag Model 1000 Surg Laser Sys/pulmon Appl.
| Device ID | K870505 |
| 510k Number | K870505 |
| Device Name: | OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL |
| Classification | Laser, Neodymium:yag, Pulmonary Surgery |
| Applicant | TRIMEDYNE, INC. 1815 EAST CARNEGIE AVE. Santa Ana, CA 92705 |
| Contact | Kimberley Doney |
| Correspondent | Kimberley Doney TRIMEDYNE, INC. 1815 EAST CARNEGIE AVE. Santa Ana, CA 92705 |
| Product Code | LLO |
| CFR Regulation Number | 874.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-04 |
| Decision Date | 1987-08-07 |