# K140381: Sensilight/ Sensilight Plus

- Pathway: 510(k) (Traditional)
- Applicant: El Global Trade, Ltd.
- Decided: Aug 8, 2014 after 175 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: 13 generations back to K950019 (1995). 42 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131870: Glide Device, Home Skinovations, Ltd. (2013) Summary page 4.
- K103184: Silk'n Flash N GO, Home Skinovations, Ltd. (2010) Summary page 4.

## Most influential descendants
- K170269: Hee HR Mini (2017), 13 descendants of its own
- K221214: Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200 (2022), 12 descendants of its own
- K230739: Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200 (2023), 11 descendants of its own
- K241998: Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP) (2024), 6 descendants of its own
- K250942: Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK) (2025), 3 descendants of its own

## Indications for use
The sensiLight™/sensiLight™ Plus device is an over-the-counter device intended for the removal of unwanted hair. The sensiLight™/sensiLight™ Plus 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/K140381
Methodology: https://510kreport.com/methodology