# K231613: Intense pulsed light device, Model (s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.

- Pathway: 510(k) (Traditional)
- Applicant: Zhuzhou Goldenhot Medical Technology Co., Ltd.
- Decided: Jul 31, 2023 after 59 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: 23 generations back to K950019 (1995). 62 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223928: Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K, Shenzhen Fansizhe Science and Technology Co., Ltd. (2023) Summary page 4.

## Most influential descendants
- K232575: Hair Removal Device, Model (s): R2815-G Pro, R2815-G (2023), 5 descendants of its own
- K242710: Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro) (2024), 3 descendants of its own
- K241120: Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S) (2024), 1 descendant of its own
- K261705: Hair Removal Device (R3C16-G Pro, R3C16-V Pro) (2026), 0 descendants of its own
- K260518: IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F) (2026), 0 descendants of its own

## Indications for use
The Intense pulsed light device is an over-the-counter device, intended for removal of unwanted body and/or facial hair.

Source page: https://510kreport.com/device/K231613
Methodology: https://510kreport.com/methodology