510(k) · Cleared
ClearedAduro light therapy Handheld
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Kaiyan Medical CO, Ltd. · OLP Over-The-Counter Powered Light Based Laser For Acne
Cleared on Jul 21, 2021 after a 257-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it.
- Decided
- Jul 21, 2021
- Review
- 257 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK203271 Aduro light therapy HandheldShenzhen Kaiyan Medical CO, Ltd. · 2021
- Descendant · cites it directly · 6 of its ownK242700 Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70…Shenzhen Nuon Medical Equipment Co., Ltd. · 2024
- Descendant · cites it directly · 2 of its ownK210545 Infrared Red blue LED light heat beauty machine, Infrared Red blue…Marci Beauty, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK250761 KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
- Descendant · 2 generations on · 1 of its ownK242151 Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69…Shenzhen Nuon Medical Equipment Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK253833 Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002…Shenzhen Jianchao Intelligent Technology Co., Ltd. · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd. · 2024 · cites it directly6descendants
- K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc. · 2022 · cites it directly2descendants
- K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025 · 2 generations on1descendant
- K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd. · 2025 · 2 generations on1descendant
- K253833Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004…Shenzhen Jianchao Intelligent Technology Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K203271 | Aduro light therapy Handheld | Shenzhen Kaiyan Medical CO, Ltd. | 2021 | — |
| +1 | K242700 | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72… | Shenzhen Nuon Medical Equipment Co., Ltd. | 2024 | — |
| +1 | K210545 | Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light… | Marci Beauty, Inc. | 2022 | — |
| +2 | K250761 | KALA Therapy Wand (Model: KALA-03) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025 | — |
| +2 | K242151 | Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A… | Shenzhen Nuon Medical Equipment Co., Ltd. | 2025 | — |
| +2 | K253833 | Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003… | Shenzhen Jianchao Intelligent Technology Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 7 | 0 |
| 2026 | 1 | 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 OLP? 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 OLP device
- #1 K214103 Shani Darden LED light therapy maskscore 25.5 · 16 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? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K242700 (Shenzhen Nuon Medical Equipment Co., Ltd., 2024) has gone furthest, with 6 descendants of its own.
How does its category compare?
All OLP devicesOLP Over-The-Counter Powered Light Based Laser For Acne: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · OLP
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLP
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLP
4in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OLP
1in 2025
MAUDE reports naming product code OLP, 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 | 1 | — | 0 | 0 |
| 2010 | 3 | 247 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 3 | 245 | 0 | 0 |
| 2014 | 3 | 255 | 0 | 1 |
| 2015 | 3 | 159 | 0 | 0 |
| 2016 | 6 | 99 | 0 | 1 |
| 2017 | 4 | 151 | 4 | 1 |
| 2018 | 5 | 104 | 0 | 7 |
| 2019 | 2 | — | 0 | 19 |
| 2020 | 1 | — | 0 | 8 |
| 2021 | 6 | 260 | 0 | 7 |
| 2022 | 5 | 245 | 0 | 1 |
| 2023 | 3 | 109 | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 3 | 88 | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Aduro light therapy Handheld (Model:HD-03A,HD-25A,HD-07A), the red light is intended for the treatment of periorbital wrinkles, and the blue light is intended for the treatment of the mild to moderate inflammatory acne.
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/K203271 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203271: Aduro light therapy Handheld.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203271
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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