# K181121: Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro

- Pathway: 510(k) (Traditional)
- Applicant: Home Well Trading, Ltd.
- Decided: Jun 28, 2018 after 59 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: 17 generations back to K950019 (1995). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161089: sensiLight Mini, El Global Trade, Ltd. (2016) Summary page 5.
- K140527: Sensilight Mini, El Global Trade, Ltd. (2014) Summary page 5.
- K161565: DUO, Stetic Medical Aesthetics Development (Shenzhen) Co.,Ltd (2016) Summary page 5.

## Indications for use
The Beurer 5500 IPL Device is an over the counter device intended for the removal of unwanted body and/ or facial hair in adults. The Beurer 5500 IPL Device is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.

Source page: https://510kreport.com/device/K181121
Methodology: https://510kreport.com/methodology