21 CFR 880.5960 — Detectors And Removers, Lice, (Including Combs)
General Hospital (HO) · Part 880 Subpart F—General Hospital and Personal Use Therapeutic Devices · § 880.5960
Identification
The lice removal kit is a comb or comb-like device intended to remove and/or kill lice and nits from head and body hair. It may or may not be battery operated.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| LJL | Detectors And Removers, Lice, (Including Combs) | 1 | 11 | |
| PUN | Lice Removal Kit Containing A Solution | 1 | 0 |
