The following data is part of a premarket notification filed by Topcon Medical Laser Systems, Inc. (tmls) with the FDA for Pascal Laser Indirect Ophthalmoscope.
| Device ID | K123056 |
| 510k Number | K123056 |
| Device Name: | PASCAL LASER INDIRECT OPHTHALMOSCOPE |
| Classification | Laser, Ophthalmic |
| Applicant | TOPCON MEDICAL LASER SYSTEMS, INC. (TMLS) 2800 PLEASANT HILL RD SUITE 175 Pleasant Hill, CA 94523 |
| Contact | Pamela M Buckman |
| Correspondent | Pamela M Buckman TOPCON MEDICAL LASER SYSTEMS, INC. (TMLS) 2800 PLEASANT HILL RD SUITE 175 Pleasant Hill, CA 94523 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-01 |
| Decision Date | 2012-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855005006140 | K123056 | 000 |
| 00855005006133 | K123056 | 000 |
| 00855005006126 | K123056 | 000 |
| 00855005006119 | K123056 | 000 |
| 00855005006102 | K123056 | 000 |
| 00813125016814 | K123056 | 000 |
| 00813125016807 | K123056 | 000 |