The following data is part of a premarket notification filed by Optek Medico Co., Ltd. with the FDA for Opm Slit Lamp Model P-1 & Model P-3.
| Device ID | K863048 |
| 510k Number | K863048 |
| Device Name: | OPM SLIT LAMP MODEL P-1 & MODEL P-3 |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | OPTEK MEDICO CO., LTD. RM.#1108, AL BERGO OCHANOMIZU 1-19, 2 CHOME, KANDA-SURUGADAI Chiyoda-ku Tokyo Japan, JP |
| Contact | Atsushi Hirayama |
| Correspondent | Atsushi Hirayama OPTEK MEDICO CO., LTD. RM.#1108, AL BERGO OCHANOMIZU 1-19, 2 CHOME, KANDA-SURUGADAI Chiyoda-ku Tokyo Japan, JP |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-12 |
| Decision Date | 1986-09-03 |