The following data is part of a premarket notification filed by Optik with the FDA for Mini Lightscope Set, Lightscope Jr. Set.
| Device ID | K894558 |
| 510k Number | K894558 |
| Device Name: | MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET |
| Classification | Arthroscope |
| Applicant | OPTIK 2131ESPEY COURT SUITE 7 Criftib, MD 21114 |
| Contact | William M Macfie |
| Correspondent | William M Macfie OPTIK 2131ESPEY COURT SUITE 7 Criftib, MD 21114 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-20 |
| Decision Date | 1989-08-07 |