The following data is part of a premarket notification filed by Electro-optical Sciences, Inc. with the FDA for Difoti System.
| Device ID | K991098 |
| 510k Number | K991098 |
| Device Name: | DIFOTI SYSTEM |
| Classification | Unit, Operative Dental |
| Applicant | ELECTRO-OPTICAL SCIENCES, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau ELECTRO-OPTICAL SCIENCES, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-01 |
| Decision Date | 1999-06-30 |
| Summary: | summary |