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 |