510(k) · Cleared
ClearedIntense Pulsed Light (IPL) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Fansizhe Science and Technology Co., Ltd. · OHT Light Based Over-The-Counter Hair Removal
Cleared on Apr 11, 2022 after a 213-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Apr 11, 2022
- Review
- 213 days
- Class
- Class II
- Product code
- OHT
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK212881 Intense Pulsed Light (IPL) SystemShenzhen Fansizhe Science and Technology Co., Ltd. · 2022
- Descendant · cites it directly · 4 of its ownK221569 Intense Pulsed Light (IPL) System, model: T013C, T015C, T015KShenzhen Fansizhe Science and Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK251173 Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ…Shenzhen Fansizhe Science and Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 1 of its ownK241120 Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S…Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK253881 Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF…Shenzhen Fansizhe Science and Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK252234 IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13…Shenzhen Qiaochengli Technology Co., Ltd. · 2025
Most influential descendants
Showing 5 of 5 · See all- K221569Intense Pulsed Light (IPL) System, model: T013C, T015C, T015KShenzhen Fansizhe Science and Technology Co., Ltd. · 2022 · cites it directly4descendants
- K251173Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF…Shenzhen Fansizhe Science and Technology Co., Ltd. · 2025 · 2 generations on1descendant
- K241120Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06…Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd. · 2024 · 2 generations on1descendant
- K253881Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD…Shenzhen Fansizhe Science and Technology Co., Ltd. · 2025 · 3 generations on0descendants
- K252234IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16…Shenzhen Qiaochengli Technology Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K212881 | Intense Pulsed Light (IPL) System | Shenzhen Fansizhe Science and Technology Co., Ltd. | 2022 | — |
| +1 | K221569 | Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K | Shenzhen Fansizhe Science and Technology Co., Ltd. | 2022 | — |
| +2 | K251173 | Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD… | Shenzhen Fansizhe Science and Technology Co., Ltd. | 2025 | — |
| +2 | K241120 | Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S… | Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd. | 2024 | — |
| +3 | K253881 | Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ… | Shenzhen Fansizhe Science and Technology Co., Ltd. | 2025 | — |
| +2 | K252234 | IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15… | Shenzhen Qiaochengli Technology Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OHT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OHT device
- #1 K221002 IPL Hair Removal Device, Model (s): UI04A…score 36.1 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221569 | Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K | 2022 | 4 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K221569 (Shenzhen Fansizhe Science and Technology Co., Ltd., 2022) has gone furthest, with 4 descendants of its own.
How does its category compare?
All OHT devicesOHT Light Based Over-The-Counter Hair Removal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · OHT
25in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OHT
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OHT
No recall names OHT since 2007.
Adverse event reports per year · OHT
6in 2025
MAUDE reports naming product code OHT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 4 | 166 | 0 | 0 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 3 | 81 | 0 | 2 |
| 2017 | 6 | 87 | 0 | 0 |
| 2018 | 8 | 89 | 0 | 0 |
| 2019 | 7 | 64 | 0 | 2 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 12 | 89 | 0 | 1 |
| 2022 | 25 | 70 | 0 | 2 |
| 2023 | 32 | 83 | 0 | 6 |
| 2024 | 26 | 62 | 0 | 0 |
| 2025 | 25 | 87 | 0 | 6 |
| 2026 | 11 | 84 | 0 | — |
What is it indicated for?
The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212881: Intense Pulsed Light (IPL) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212881
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026