The following data is part of a premarket notification filed by Topcon Medical Laser Systems, Inc with the FDA for Pascal Photocoagulator, Product-pascal-01.
| Device ID | K043486 |
| 510k Number | K043486 |
| Device Name: | PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01 |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-17 |
| Decision Date | 2005-03-03 |
| Summary: | summary |