The following data is part of a premarket notification filed by Optical Systems Intl., Inc. with the FDA for Ultrathin/sp Lens.
| Device ID | K843957 |
| 510k Number | K843957 |
| Device Name: | ULTRATHIN/SP LENS |
| Classification | Engine, Trephine, Accessories, Ac-powered |
| Applicant | OPTICAL SYSTEMS INTL., INC. 1652 W. 32ND. PLACE Hialeah, FL 33012 |
| Contact | Edward Derajas |
| Correspondent | Edward Derajas OPTICAL SYSTEMS INTL., INC. 1652 W. 32ND. PLACE Hialeah, FL 33012 |
| Product Code | HRG |
| CFR Regulation Number | 886.4070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-10 |
| Decision Date | 1985-07-31 |