Definition: A Powered Corneal Burr Is An AC-powered Or Battery-powered Device That Is A Motor And Drilling Tool Intended To Remove Rust Rings From The Cornea Of The Eye And Is Class I Exempt When Intended Only For Rust Ring Removal.
| Device Type ID | 4396 |
| Device Name | Burr, Corneal, Battery Powered, Rust Ring Removal |
| Physical State | A Powered Corneal Burr Is An AC-powered Or Battery-powered Device That Is A Motor And Drilling Tool Intended To Remove Rust Rings From The Cornea Of The Eye And Is Class I Exempt When Intended Only For Rust Ring Removal. |
| Technical Method | A Powered Corneal Burr Is An AC-powered Or Battery-powered Device That Is A Motor And Drilling Tool Intended To Remove Rust Rings From The Cornea Of The Eye And Is Class I Exempt When Intended Only For Rust Ring Removal. |
| Target Area | A Powered Corneal Burr Is An AC-powered Or Battery-powered Device That Is A Motor And Drilling Tool Intended To Remove Rust Rings From The Cornea Of The Eye And Is Class I Exempt When Intended Only For Rust Ring Removal. |
| Regulation Description | Powered Corneal Burr. |
| 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) Exempt |
| CFR Regulation Number | 886.4070 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OHW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4396 |
| Device | Burr, Corneal, Battery Powered, Rust Ring Removal |
| Product Code | OHW |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Powered Corneal Burr. |
| CFR Regulation Number | 886.4070 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Bausch & Lomb, Inc. | II | Jan-10-2017 |