KOWA PORTABLE SLIT LAMP SL-14 & SL-14B
Device Facts
| Record ID | K954782 |
|---|---|
| Device Name | KOWA PORTABLE SLIT LAMP SL-14 & SL-14B |
| Applicant | Kowa Optimed, Inc. |
| Product Code | HJO · Ophthalmic |
| Decision Date | Nov 24, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1850 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.
Special Controls
*Classification.* Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
