LASER IMAGING WORK STATION
Device Facts
| Record ID | K897186 |
|---|---|
| Device Name | LASER IMAGING WORK STATION |
| Applicant | Innovision Medical, Inc. |
| Product Code | HJI · Ophthalmic |
| Decision Date | Mar 12, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1395 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A diagnostic Hruby fundus lens is a device that is a 55 diopter lens intended for use in the examination of the vitreous body and the fundus of the eye under slitlamp illumination and magnification.
