CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)
Device Facts
| Record ID | K000637 |
|---|---|
| Device Name | CUSTOMCORNEA MEASUREMENT DEVICE (CCMD) |
| Applicant | Alcon Laboratories, Inc. |
| Product Code | NCF · Ophthalmic |
| Decision Date | May 19, 2000 |
| Decision | SESU |
| 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.
