The following data is part of a premarket notification filed by Phoenix Laser Systems, Inc. with the FDA for Phoenix Laser Systems Ophthalmic Surgical Worksta..
| Device ID | K901605 |
| 510k Number | K901605 |
| Device Name: | PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA. |
| Classification | Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla |
| Applicant | PHOENIX LASER SYSTEMS, INC. 205 25TH AVENUE NORTH St. Petersburg, FL 33704 |
| Contact | Joann R Schulz |
| Correspondent | Joann R Schulz PHOENIX LASER SYSTEMS, INC. 205 25TH AVENUE NORTH St. Petersburg, FL 33704 |
| Product Code | LXS |
| CFR Regulation Number | 886.4392 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-05 |
| Decision Date | 1990-12-13 |