The following data is part of a premarket notification filed by Neo Optics, Inc. with the FDA for Krom-x Lens System.
| Device ID | K865103 |
| 510k Number | K865103 |
| Device Name: | KROM-X LENS SYSTEM |
| Classification | Lens, Spectacle, Non-custom (prescription) |
| Applicant | NEO OPTICS, INC. 636 E. COLORADO AVE. Glendale, CA 91205 |
| Contact | Henry Schumer |
| Correspondent | Henry Schumer NEO OPTICS, INC. 636 E. COLORADO AVE. Glendale, CA 91205 |
| Product Code | HQG |
| CFR Regulation Number | 886.5844 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-30 |
| Decision Date | 1987-01-20 |