EASYSCAN MODEL 1.2
Device Facts
| Record ID | K111988 |
|---|---|
| Device Name | EASYSCAN MODEL 1.2 |
| Applicant | I-Optics BV |
| Product Code | MYC · Ophthalmic |
| Decision Date | Oct 28, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1570 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.
Special Controls
*Classification.* Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
