# K181734: Beurer IPL 8500 device/ IPL VelvetSkin Pro

- Pathway: 510(k) (Traditional)
- Applicant: Home Well Trading, Ltd.
- Decided: Sep 19, 2018 after 79 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: 15 generations back to K950019 (1995). 46 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 48 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 7.
- K172791: Lumilisse IPL Hair Remover, Conair Corporation (2018) Summary page 7.

## Most influential descendants
- K183260: Sensilight Pro / Pistol IPL (2019), 0 descendants of its own

## Indications for use
The IPL 8500 device is an over-the-counter device intended for the removal of unwanted body and/or facial hair. IPL 8500 is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen.

Source page: https://510kreport.com/device/K181734
Methodology: https://510kreport.com/methodology