The following data is part of a premarket notification filed by Optik with the FDA for Lightscope Set.
| Device ID | K894557 |
| 510k Number | K894557 |
| Device Name: | LIGHTSCOPE SET |
| Classification | Dynamometer, Nonpowered |
| Applicant | OPTIK 2131ESPEY COURT SUITE 7 Criftib, MD 21114 |
| Contact | Williams M Macfie |
| Correspondent | Williams M Macfie OPTIK 2131ESPEY COURT SUITE 7 Criftib, MD 21114 |
| Product Code | HRW |
| CFR Regulation Number | 888.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-20 |
| Decision Date | 1989-08-07 |