The following data is part of a premarket notification filed by Topcon Medical Systems, Inc. with the FDA for Slit Lamp Sl-2g.
| Device ID | K110489 |
| 510k Number | K110489 |
| Device Name: | SLIT LAMP SL-2G |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | TOPCON MEDICAL SYSTEMS, INC. 5 TIMBER LANE North Reading, MA 01864 |
| Contact | Maureen O'connell |
| Correspondent | Maureen O'connell TOPCON MEDICAL SYSTEMS, INC. 5 TIMBER LANE North Reading, MA 01864 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-22 |
| Decision Date | 2011-05-23 |
| Summary: | summary |