Definition: This Device Type Is Intended To Cleanse The Eyelid Margins And Eyelashes By A Healthcare Professional.
| Device Type ID | 4428 |
| Device Name | Sponge, Eyelid Cleaning, Powered |
| Physical State | The Eyelid Cleaning Device Is A Handheld Device That Spins A Soft Micro-sponge In The Horizontal Axis. The Handpiece Is Made Out Of Stainless Steel And Plastic, And The Micro-sponge Is Composed Of Polyvinyl Alcohol. The Handpiece Works With A Lithium |
| Technical Method | The Eyelid Cleaning Device Is A Device That Cleanses The Eyelid Margins Using A Medical Grade Micro-sponge And Eyelid Cleansing Foam. The Micro-sponge Is Applied To The Lower And Upper Eyelid Margins And Eyelashes To Remove Debris. A Healthcare Profe |
| Target Area | The Target Area Is The Eyelid Margins. |
| Regulation Description | Surgical Instrument Motors And Accessories/attachments. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Contact Lenses And Retinal Devices Branch (CLRD) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4820 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | PYU |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4428 |
| Device | Sponge, Eyelid Cleaning, Powered |
| Product Code | PYU |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Surgical Instrument Motors And Accessories/attachments. |
| CFR Regulation Number | 878.4820 [🔎] |