RETURN PATH DIATHERMY HANDLE
Device Facts
| Record ID | K941495 |
|---|---|
| Device Name | RETURN PATH DIATHERMY HANDLE |
| Applicant | Mira, Inc. |
| Product Code | HQR · Ophthalmic |
| Decision Date | Jul 15, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4100 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.
