The following data is part of a premarket notification filed by Robert B. Scott Ocularists Of Florida, Inc. with the FDA for Moldeye.
| Device ID | K772168 |
| 510k Number | K772168 |
| Device Name: | MOLDEYE |
| Classification | Conformer, Ophthalmic |
| Applicant | ROBERT B. SCOTT OCULARISTS OF FLORIDA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HQN |
| CFR Regulation Number | 886.3130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-11-08 |
| Decision Date | 1977-11-30 |