OTI MODEL TLS-60
Device Facts
| Record ID | K951437 |
|---|---|
| Device Name | OTI MODEL TLS-60 |
| Applicant | Oti Medical, LLC |
| Product Code | HPC · Ophthalmic |
| Decision Date | Apr 11, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1405 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An ophthalmic trial lens set is a device that is a set of lenses of various dioptric powers intended to be handheld or inserted in a trial frame for vision testing to determine refraction.
