LENS
Device Facts
| Record ID | K821897 |
|---|---|
| Device Name | LENS |
| Applicant | Mortan, Inc. |
| Product Code | KYG · Ophthalmic |
| Decision Date | Jan 5, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4360 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An ocular surgery irrigation device is a device intended to be suspended over the ocular area during ophthalmic surgery to deliver continuous, controlled irrigation to the surgical field.
