# K183260: Sensilight Pro / Pistol IPL

- Pathway: 510(k) (Traditional)
- Applicant: El Global Trade, Ltd.
- Decided: Mar 18, 2019 after 115 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: 16 generations back to K950019 (1995). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181734: Beurer IPL 8500 device/ IPL VelvetSkin Pro, Home Well Trading, Ltd. (2018) Summary page 6.
- K161089: sensiLight Mini, El Global Trade, Ltd. (2016) Summary page 6.

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

Source page: https://510kreport.com/device/K183260
Methodology: https://510kreport.com/methodology