The following data is part of a premarket notification filed by Electro-optical Sciences, Inc. with the FDA for Difoti Usb 2.0 System.
| Device ID | K043068 |
| 510k Number | K043068 |
| Device Name: | DIFOTI USB 2.0 SYSTEM |
| Classification | Caries Detector, Laser Light, Transmission |
| Applicant | ELECTRO-OPTICAL SCIENCES, INC. 1 BRIDGE ST. SUITE 15 Irvington-on Hudson, NY 10533 |
| Contact | Michael Greenebaum |
| Correspondent | Michael Greenebaum ELECTRO-OPTICAL SCIENCES, INC. 1 BRIDGE ST. SUITE 15 Irvington-on Hudson, NY 10533 |
| Product Code | NTK |
| CFR Regulation Number | 872.1745 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-08 |
| Decision Date | 2004-12-29 |
| Summary: | summary |