The following data is part of a premarket notification filed by Optik with the FDA for Optik Laparoscope.
| Device ID | K933776 |
| 510k Number | K933776 |
| Device Name: | OPTIK LAPAROSCOPE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | OPTIK 1370 BLAIR DR. Odenton, MD 21113 |
| Contact | William M Macfie |
| Correspondent | William M Macfie OPTIK 1370 BLAIR DR. Odenton, MD 21113 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-03 |
| Decision Date | 1994-03-16 |