XOMED THERMAL MYRINGOTOMY SYSTEM
Device Facts
| Record ID | K820157 |
|---|---|
| Device Name | XOMED THERMAL MYRINGOTOMY SYSTEM |
| Applicant | Xomed, Inc. |
| Product Code | HQP · Ophthalmic |
| Decision Date | Mar 2, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4115 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by heat conducted through a wire tip.
