The following data is part of a premarket notification filed by Nk-optik America with the FDA for Lc-250 Infrared Light Coagulator.
| Device ID | K964380 |
| 510k Number | K964380 |
| Device Name: | LC-250 INFRARED LIGHT COAGULATOR |
| Classification | Photocoagulator And Accessories |
| Applicant | NK-OPTIK AMERICA 1819 SOUTH MAY ST., 2F Chicago, IL 60608 |
| Contact | Robert W Bauer, Ph.d. |
| Correspondent | Robert W Bauer, Ph.d. NK-OPTIK AMERICA 1819 SOUTH MAY ST., 2F Chicago, IL 60608 |
| Product Code | HQB |
| CFR Regulation Number | 886.4690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-04 |
| Decision Date | 1997-01-22 |