# K221214: Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Ionka Medical Technology Co., Ltd.
- Decided: Sep 21, 2022 after 147 days
- Product code: ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect)
- 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). 62 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160968: iPulse SmoothSkin Gold Hair Removal Device, Cyden Limited (2016) Summary page 5.
- K170269: Hee HR Mini, Oriental Inspiration Limited (2017) Summary page 5.
- K213558: IPL Hair Removal Device, Ulike Co., Ltd. (2022) Summary page 5.
- K212907: Aimanfun Lumea Comfort, A-2789/A-3588, Kam Yuen Plastic Products, Ltd. (2021) Summary page 5.

## Most influential descendants
- 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
- K251000: Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) (2025), 1 descendant of its own
- K243036: IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL-25, BHRL-26, BHRL-27, BHRL-28, BHRL-29) (2025), 1 descendant of its own

## Indications for use
IPL home use hair removal device is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. The IPL home use hair removal device is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen. The device is used for adults with Fitzpatrick skin types I – V.

Source page: https://510kreport.com/device/K221214
Methodology: https://510kreport.com/methodology