Definition: Used To Perform Anterior Capsulotomy During Cataract Surgery
| Device Type ID | 4413 |
| Device Name | Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-powered |
| Physical State | RF Power Console And Handpiece. The Handpiece Has The Cutting Element That Delivers Energy For Capsulotomy. |
| Technical Method | A Corneal Incision Is Made Into The Anterior Chamber Of The Eye. A Cutting Element Is Inserted Through The Incision And Centered On The Lens Capsule. Energy Is Directed To The Cutting Element, Creating The Capsulotomy. The Cutting Element Is Removed |
| Target Area | Cornea Of The Eye |
| 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 | PUL |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4413 |
| Device | Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-powered |
| Product Code | PUL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Radiofrequency Electrosurgical Cautery Apparatus. |
| CFR Regulation Number | 886.4100 [🔎] |