The following data is part of a premarket notification filed by Hoya Corp. Usa with the FDA for Al-3300.
| Device ID | K940997 |
| 510k Number | K940997 |
| Device Name: | AL-3300 |
| Classification | Instrument, Measuring, Lens, Ac-powered |
| Applicant | HOYA CORP. USA ONE CANON PLAZA Lake Success, NY 11042 |
| Contact | Koichi Yano |
| Correspondent | Koichi Yano HOYA CORP. USA ONE CANON PLAZA Lake Success, NY 11042 |
| Product Code | HLM |
| CFR Regulation Number | 886.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-04 |
| Decision Date | 1994-09-29 |