MAKROLON 2405 GOGGLES (LIGHT AND DARK)
Device Facts
| Record ID | K945346 |
|---|---|
| Device Name | MAKROLON 2405 GOGGLES (LIGHT AND DARK) |
| Applicant | Universal Massage & Tanning, Inc. |
| Product Code | HOY · Ophthalmic |
| Decision Date | Nov 22, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4750 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place.