The following data is part of a premarket notification filed by Stellar Contact Lens, Inc. with the FDA for Op-2 (lotifocon B) & Op-6 (lotifocon C).
| Device ID | K952260 |
| 510k Number | K952260 |
| Device Name: | OP-2 (LOTIFOCON B) & OP-6 (LOTIFOCON C) |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | STELLAR CONTACT LENS, INC. 203 N. WABASH AVE, STE 1200 Chicago, IL 60601 |
| Contact | John M Szabocsik |
| Correspondent | John M Szabocsik STELLAR CONTACT LENS, INC. 203 N. WABASH AVE, STE 1200 Chicago, IL 60601 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-15 |
| Decision Date | 1996-01-03 |