The following data is part of a premarket notification filed by Leica, Inc. with the FDA for Xcel Slit Lamp.
| Device ID | K951054 |
| 510k Number | K951054 |
| Device Name: | XCEL SLIT LAMP |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | LEICA, INC. P.O. BOX 123 Buffalo, NY 14240 -0123 |
| Contact | Frank J Drexelium |
| Correspondent | Frank J Drexelium LEICA, INC. P.O. BOX 123 Buffalo, NY 14240 -0123 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-07 |
| Decision Date | 1995-03-22 |