The following data is part of a premarket notification filed by Asahi Optical Co. C/o Rosati Associates, P.c. with the FDA for Zimlite Lens.
| Device ID | K861960 |
| 510k Number | K861960 |
| Device Name: | ZIMLITE LENS |
| Classification | Lens, Spectacle, Non-custom (prescription) |
| Applicant | ASAHI OPTICAL CO. C/O ROSATI ASSOCIATES, P.C. 3-23. 5-CHOME HINODE. FUKUI-CITY 910 Japan, JP |
| Contact | Tekeuchi |
| Correspondent | Tekeuchi ASAHI OPTICAL CO. C/O ROSATI ASSOCIATES, P.C. 3-23. 5-CHOME HINODE. FUKUI-CITY 910 Japan, JP |
| Product Code | HQG |
| CFR Regulation Number | 886.5844 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-20 |
| Decision Date | 1986-06-09 |