INFINITY MICRO IRRIGATOR
Device Facts
| Record ID | K924052 |
|---|---|
| Device Name | INFINITY MICRO IRRIGATOR |
| Applicant | Infinity Surgical Technology, Inc. |
| Product Code | KYG · Ophthalmic |
| Decision Date | Dec 23, 1992 |
| 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.