The following data is part of a premarket notification filed by Optical Radiation Corp. with the FDA for Orc Oracle.
| Device ID | K853668 |
| 510k Number | K853668 |
| Device Name: | ORC ORACLE |
| Classification | Keratoscope, Ac-powered |
| Applicant | OPTICAL RADIATION CORP. 1300 OPTICAL DR. Azusa, CA 91702 |
| Contact | Charmaine Henderson |
| Correspondent | Charmaine Henderson OPTICAL RADIATION CORP. 1300 OPTICAL DR. Azusa, CA 91702 |
| Product Code | HLQ |
| CFR Regulation Number | 886.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-03 |
| Decision Date | 1985-10-15 |