510(k) · Cleared
ClearedIPL Hair Removal Device (KCA511/KCA516/KCA522)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dongguan Boyuan Intelligent Technology Co.,Ltd · OHT Light Based Over-The-Counter Hair Removal
Cleared on May 6, 2025 as substantially equivalent to K240282 (Dongguan Boyuan Intelligent Technology Co.,Ltd, 2024) after a 98-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- May 6, 2025
- Review
- 98 days
- Class
- Class II
- Product code
- OHT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K240282 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backK240282 IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505…Dongguan Boyuan Intelligent Technology Co.,Ltd · 2024
- This deviceK250253 IPL Hair Removal Device (KCA511/KCA516/KCA522)Dongguan Boyuan Intelligent Technology Co.,Ltd · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K240282 | IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506… | Dongguan Boyuan Intelligent Technology Co.,Ltd | 2024 | — |
| 0 (this device) | K250253 | IPL Hair Removal Device (KCA511/KCA516/KCA522) | Dongguan Boyuan Intelligent Technology Co.,Ltd | 2025 | — |
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 |
|---|---|---|---|
| * | K240282 | IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508…Summary page 5…III. PREDICATE DEVICE Predicate device: Manufacturer Predicate Device 510(k) Number Approval Date Dongguan Boyuan IPL Hair Removal K240282 April 3, 2024 Intelligent Device Technology Co.,Ltd. This predicate has not been subject to a design-rela… | 2024 |
| † | K230122 | IPL Hair Removal Device, Model (s): UI04 SD, UI04 DG | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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?
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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 regime.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250253: IPL Hair Removal Device (KCA511/KCA516/KCA522).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250253
Report an extraction error
Are you the manufacturer?
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