Definition: To Remove Lice Eggs From Hair
| Device Type ID | 2758 |
| Device Name | Lice Removal Kit Containing A Solution |
| Physical State | The Kit Is Composed Of A Comb Or Comb-like Device, And A Solution Intended To Remove And/or Kill Lice And Nits. |
| Technical Method | The Solution Is Intended To Remove And/or Kill Lice And Nits; The Solution Also May Lubricate The Hair To Facilitate Removal Of Dead Lice And Nits With The Supplied Comb. |
| Target Area | Human Head Including Hair Scalp |
| Regulation Description | Lice Removal Kit. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.5960 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | PUN |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2758 |
| Device | Lice Removal Kit Containing A Solution |
| Product Code | PUN |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Lice Removal Kit. |
| CFR Regulation Number | 880.5960 [🔎] |