The following data is part of a premarket notification filed by Topcon Medical Laser Systems, Inc with the FDA for Pascal Streamline Photocoagulator.
Device ID | K092621 |
510k Number | K092621 |
Device Name: | PASCAL STREAMLINE PHOTOCOAGULATOR |
Classification | Laser, Ophthalmic |
Applicant | TOPCON MEDICAL LASER SYSTEMS, INC 3130 CORONADO DRIVE Santa Clara, CA 95054 |
Contact | John Jossy |
Correspondent | John Jossy TOPCON MEDICAL LASER SYSTEMS, INC 3130 CORONADO DRIVE Santa Clara, CA 95054 |
Product Code | HQF |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-08-26 |
Decision Date | 2009-09-25 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() PASCAL STREAMLINE PHOTOCOAGULATOR 77708955 not registered Dead/Abandoned |
OptiMedica Corporation 2009-04-07 |