SURGITRON
Device Facts
| Record ID | K955158 |
|---|---|
| Device Name | SURGITRON |
| Applicant | Ellman Intl., Inc. |
| Product Code | HQR · Ophthalmic |
| Decision Date | Feb 9, 1996 |
| 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.
