The following data is part of a premarket notification filed by I-optics Bv with the FDA for Easyscan Model 1.2.
| Device ID | K111988 |
| 510k Number | K111988 |
| Device Name: | EASYSCAN MODEL 1.2 |
| Classification | Ophthalmoscope, Laser, Scanning |
| Applicant | I-OPTICS BV 220 RIVER ROAD Claremont, NH 03743 |
| Contact | William Greenrose |
| Correspondent | William Greenrose I-OPTICS BV 220 RIVER ROAD Claremont, NH 03743 |
| Product Code | MYC |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-13 |
| Decision Date | 2011-10-28 |