510(k) · Cleared
ClearedLLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Cosbeauty Technology Co., Ltd. · OAP Laser, Comb, Hair
Cleared on Jan 19, 2022 as substantially equivalent to K201854 (Nature, Inc.redible, Inc., 2020) after an 86-day review. Its family tree reaches back 8 generations to 2007. 2 later devices descend from it.
- Decided
- Jan 19, 2022
- Review
- 86 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K060305 (2007). 14 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK060305 Hairmax LasercombLexington International, LLC · 2007
- 7 generations backK093499 Hairmax LasercombLexington International, LLC · 2009
- 6 generations backK103368 Hairmax LasercombLexington International, LLC · 2011
- 5 generations backK142573 HairMax LaserComb, HairMax LaserCombLexington International, LLC · 2014
- 4 generations backK160285 Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Capillus, LLC · 2016
- 3 generations backK162071 IllumiFlow Laser CapEglobal, LLC · 2017
- 2 generations backK173678 Diode Laser CapCosmo Far East Technology Limited · 2018
- 1 generation backK201854 CAPOGEN Laser CapNature, Inc.redible, Inc. · 2020
- This deviceK213447 LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair…Shenzhen Cosbeauty Technology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK260899 Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155…Zdeer Technology (Henan) Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK232356 Laser Cap, Model: Hat-01Hubei Yjt Technology Co.,Ltd · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K060305 | Hairmax Lasercomb | Lexington International, LLC | 2007 | — |
| −7 | K093499 | Hairmax Lasercomb | Lexington International, LLC | 2009 | — |
| −6 | K103368 | Hairmax Lasercomb | Lexington International, LLC | 2011 | — |
| −5 | K142573 | HairMax LaserComb, HairMax LaserComb | Lexington International, LLC | 2014 | — |
| −4 | K160285 | Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202 | Capillus, LLC | 2016 | — |
| −3 | K162071 | IllumiFlow Laser Cap | Eglobal, LLC | 2017 | — |
| −2 | K173678 | Diode Laser Cap | Cosmo Far East Technology Limited | 2018 | — |
| −1 | K201854 | CAPOGEN Laser Cap | Nature, Inc.redible, Inc. | 2020 | — |
| 0 (this device) | K213447 | LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210. | Shenzhen Cosbeauty Technology Co., Ltd. | 2022 | — |
| +1 | K260899 | Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156… | Zdeer Technology (Henan) Co., Ltd. | 2026 | — |
| +1 | K232356 | Laser Cap, Model: Hat-01 | Hubei Yjt Technology Co.,Ltd | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 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 OAP? 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 OAP device
- #1 K222790 F65 Laser Systemscore 20.5 · 21 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 |
|---|---|---|---|
| * | K201854 | CAPOGEN Laser CapSummary page 4…sor Nature Incredible Inc. Device Name and Model CAPOGEN Laser Cap, model: CG-148, CG-272 510(k) Number K201854 Product Code OAP Regulation Number 21 CFR 890.5500 Regulation Class… | 2020 |
| † | K203826 | LaserCap Family of Lasers 300, 224, 120 & 80 | 2021 |
What descends from it? (2)
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?
- The line of descent spans 15 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K260899 (Zdeer Technology (Henan) Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · OAP
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAP
No recall names OAP since 2007.
Adverse event reports per year · OAP
11in 2025
MAUDE reports naming product code OAP, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 89 | 0 | 1 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 3 | 262 | 0 | 1 |
| 2014 | 3 | 80 | 0 | 0 |
| 2015 | 8 | 126 | 0 | 2 |
| 2016 | 8 | 83 | 0 | 1 |
| 2017 | 5 | 83 | 0 | 1 |
| 2018 | 15 | 87 | 0 | 1 |
| 2019 | 9 | 89 | 0 | 4 |
| 2020 | 9 | 88 | 0 | 0 |
| 2021 | 5 | 89 | 0 | 3 |
| 2022 | 8 | 99 | 0 | 2 |
| 2023 | 8 | 81 | 0 | 0 |
| 2024 | 10 | 94 | 0 | 1 |
| 2025 | 6 | 87 | 0 | 11 |
| 2026 | 9 | 83 | 0 | — |
What is it indicated for?
LLLT Laser Hair Growth Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213447 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213447: LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213447
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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