# K243030: Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)

- Pathway: 510(k) (Special)
- Applicant: Ulike Co., Ltd.
- Decided: Oct 25, 2024 after 28 days
- Product code: OHT (Light Based Over-The-Counter Hair Removal)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K950019 (1995). 63 ancestors in all.
No later device cites it as a predicate yet.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221553: Diamond Air+ (UI04A, UI04B, UI04C), Ulike Co., Ltd. (2022) Summary page 6.

## Indications for use
Diamond Air+ is an over-the-counter device intended for removal of unwanted body and/or facial hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Source page: https://510kreport.com/device/K243030
Methodology: https://510kreport.com/methodology