OPTEC 3000
Device Facts
| Record ID | K924741 |
|---|---|
| Device Name | OPTEC 3000 |
| Applicant | Stereo Optical Co., Inc. |
| Product Code | HKO · Ophthalmic |
| Decision Date | Apr 6, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1760 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system, a measurement and recording system, and an alignment system intended to measure the refractive power of the eye by measuring light reflexes from the retina.
