510(k) · Cleared
ClearedIntense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF)
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 Jul 14, 2025 as substantially equivalent to K221569 (Shenzhen Fansizhe Science and Technology Co., Ltd., 2022) after an 89-day review. Its family tree reaches back 2 generations to 2022. 1 later device descends from it.
- Decided
- Jul 14, 2025
- Review
- 89 days
- Class
- Class II
- Product code
- OHT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K212881 (2022). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK212881 Intense Pulsed Light (IPL) SystemShenzhen Fansizhe Science and Technology Co., Ltd. · 2022
- 1 generation backK221569 Intense Pulsed Light (IPL) System, model: T013C, T015C, T015KShenzhen Fansizhe Science and Technology Co., Ltd. · 2022
- This deviceK251173 Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ…Shenzhen Fansizhe Science and Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK253881 Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF…Shenzhen Fansizhe Science and Technology Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K253881Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD…Shenzhen Fansizhe Science and Technology Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K251173 | Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD… | Shenzhen Fansizhe Science and Technology Co., Ltd. | 2025 | — |
| +1 | K253881 | Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ… | Shenzhen Fansizhe Science and Technology Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K221569 | Intense Pulsed Light (IPL) System, model: T013C, T015C, T015KSummary page 6…510(k) Number Shenzhen Fansizhe Science And Intense Pulsed Light (IPL) System, Model: T013C, T015C, T015K K221569 Technology Co., Ltd Reference Device 1 Manufacturer Reference Device… | 2022 |
| † | K241998 | Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S… | 2024 |
| † | K230739 | Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100… | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253881 | Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD… | 2025 | 0 |
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?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 3.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K253881 (Shenzhen Fansizhe Science and Technology Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K221569.
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. 2025, 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 as stated in the FDA summary.
https://510kreport.com/device/K251173 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251173: Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251173
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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