| Device Type ID | 4305 |
| Device Name | Apparatus, Cautery, Radiofrequency, Ac-powered |
| Regulation Description | Radiofrequency Electrosurgical Cautery Apparatus. |
| Regulation Medical Specialty | Ophthalmic |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Diagnostic And Surgical Devices Branch (DSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 886.4100 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HQR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 4305 |
| Device | Apparatus, Cautery, Radiofrequency, Ac-powered |
| Product Code | HQR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Radiofrequency Electrosurgical Cautery Apparatus. |
| CFR Regulation Number | 886.4100 [🔎] |
| Device Problems | |
|---|---|
Crack | 2 |
Inaccurate Delivery | 1 |
Break | 1 |
Device Operational Issue | 1 |
| Total Device Problems | 5 |