The following data is part of a premarket notification filed by Aura Lens Products with the FDA for Auralite Ii.
| Device ID | K852403 |
| 510k Number | K852403 |
| Device Name: | AURALITE II |
| Classification | Lens, Spectacle, Non-custom (prescription) |
| Applicant | AURA LENS PRODUCTS P.O. BOX 763 St. Cloud, MN 56302 -0763 |
| Contact | Robert N Aurelius |
| Correspondent | Robert N Aurelius AURA LENS PRODUCTS P.O. BOX 763 St. Cloud, MN 56302 -0763 |
| Product Code | HQG |
| CFR Regulation Number | 886.5844 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-06 |
| Decision Date | 1985-08-20 |