# K212314: IPL Hair Removal Device

- Pathway: 510(k) (Traditional)
- Applicant: Zhongshan Bisen Plastic Electronic Products Co., Ltd.
- Decided: Oct 21, 2021 after 90 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: 20 generations back to K950019 (1995). 58 ancestors in all.
23 later devices descend from it; 1 cites it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192432: IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129, D-1130, Shenzhen Bosidin Technology Co., Ltd. (2019) Summary page 5.

## Most influential descendants
- K214113: Hand-held IPL device (JOVS Graphene Hair Removal Device) (2022), 22 descendants of its own
- K220645: Hand-held IPL device (JOVS Hair Removal Device) (2022), 19 descendants of its own
- K230360: IPL Cooling Hair Removal Device, Model (s): NBB01, NBB02 (2023), 17 descendants of its own
- K231717: IPL Home Use Hair Removal Device, Model (s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022 (2023), 11 descendants of its own
- K240016: IPL Hair Removal Device (YT01,YT02,YT03,YT04) (2024), 9 descendants of its own

## Indications for use
The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.

Source page: https://510kreport.com/device/K212314
Methodology: https://510kreport.com/methodology