The following data is part of a premarket notification filed by Visiomed Ag with the FDA for Microderm, Model/version 3.5.
| Device ID | K040171 |
| 510k Number | K040171 |
| Device Name: | MICRODERM, MODEL/VERSION 3.5 |
| Classification | Light Based Imaging |
| Applicant | VISIOMED AG 20310 SW 48TH STREET Ft. Lauderdale, FL 33332 |
| Contact | John Greenbaum |
| Correspondent | John Greenbaum VISIOMED AG 20310 SW 48TH STREET Ft. Lauderdale, FL 33332 |
| Product Code | PSN |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-26 |
| Decision Date | 2004-06-08 |
| Summary: | summary |