The following data is part of a premarket notification filed by Topcon Medical Laser Systems, Inc with the FDA for Pascal Synthesis (532nm/577nm) Opthalmic Laser.
| Device ID | K123542 |
| 510k Number | K123542 |
| Device Name: | PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER |
| Classification | Laser, Ophthalmic |
| Applicant | TOPCON MEDICAL LASER SYSTEMS, INC 2800 PLEASANT HILL RD., SUITE 175 Pleasant Hill, CA 94553 |
| Contact | Pamela M Buckman |
| Correspondent | Pamela M Buckman TOPCON MEDICAL LASER SYSTEMS, INC 2800 PLEASANT HILL RD., SUITE 175 Pleasant Hill, CA 94553 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-19 |
| Decision Date | 2013-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855005006201 | K123542 | 000 |
| 00855005006249 | K123542 | 000 |
| 00813125016661 | K123542 | 000 |
| 00813125016760 | K123542 | 000 |
| 00813125015602 | K123542 | 000 |
| 00813125015497 | K123542 | 000 |
| 00813125016777 | K123542 | 000 |
| 00813125016753 | K123542 | 000 |
| 00813125016746 | K123542 | 000 |
| 00813125016739 | K123542 | 000 |
| 00813125016722 | K123542 | 000 |
| 00813125016715 | K123542 | 000 |
| 00813125016708 | K123542 | 000 |
| 00813125015534 | K123542 | 000 |
| 00813125015527 | K123542 | 000 |
| 00855005006256 | K123542 | 000 |
| 00855005006270 | K123542 | 000 |
| 00855005006195 | K123542 | 000 |
| 00855005006164 | K123542 | 000 |
| 00855005006157 | K123542 | 000 |
| 00855005006096 | K123542 | 000 |
| 00855005006089 | K123542 | 000 |
| 00855005006072 | K123542 | 000 |
| 00855005006065 | K123542 | 000 |
| 00855005006058 | K123542 | 000 |
| 00855005006041 | K123542 | 000 |
| 00855005006034 | K123542 | 000 |
| 00855005006027 | K123542 | 000 |
| 00855005006010 | K123542 | 000 |
| 00855005006003 | K123542 | 000 |
| 00855005006287 | K123542 | 000 |
| 00813125015503 | K123542 | 000 |