510(k) · Cleared
ClearedHair Growth Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd. · OAP Laser, Comb, Hair
Cleared on Apr 16, 2021 as substantially equivalent to K200464 (Lg Electronics.Inc, 2020) and 1 other predicate after an 84-day review. Its family tree reaches back 7 generations to 2007. 6 later devices descend from it.
- Decided
- Apr 16, 2021
- Review
- 84 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K060305 (2007). 13 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK060305 Hairmax LasercombLexington International, LLC · 2007
- 6 generations backK093499 Hairmax LasercombLexington International, LLC · 2009
- 5 generations backK103368 Hairmax LasercombLexington International, LLC · 2011
- 4 generations backK142573 HairMax LaserComb, HairMax LaserCombLexington International, LLC · 2014
- 3 generations backK160285 Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Capillus, LLC · 2016
- 2 generations backK162071 IllumiFlow Laser CapEglobal, LLC · 2017
- 1 generation backK200464 LG Pra. L Derma LD Scalp CareLg Electronics.Inc · 2020
- This deviceK210169 Hair Growth DeviceDongguan Lescolton Intelligent Electrical Appliance Co., Ltd. · 2021
- Descendant · cites it directly · 2 of its ownK222477 Hair Growth DeviceDongguan Lescolton Medical Equipment Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK231153 Neuhat Hair Growth System; ibeauty.com Laser CapNature, Inc.redible, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK262183 Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A…Shenzhen Nuon Medical Equipment Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK251017 CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK242747 FAQ™ (302)Foreo, Inc. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K222477Hair Growth DeviceDongguan Lescolton Medical Equipment Co., Ltd. · 2022 · cites it directly2descendants
- K231153Neuhat Hair Growth System; ibeauty.com Laser CapNature, Inc.redible, Inc. · 2023 · cites it directly1descendant
- K262183Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)Shenzhen Nuon Medical Equipment Co., Ltd. · 2026 · 2 generations on0descendants
- K251017CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025 · 2 generations on0descendants
- K242747FAQ™ (302)Foreo, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K060305 | Hairmax Lasercomb | Lexington International, LLC | 2007 | — |
| −6 | K093499 | Hairmax Lasercomb | Lexington International, LLC | 2009 | — |
| −5 | K103368 | Hairmax Lasercomb | Lexington International, LLC | 2011 | — |
| −4 | K142573 | HairMax LaserComb, HairMax LaserComb | Lexington International, LLC | 2014 | — |
| −3 | K160285 | Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202 | Capillus, LLC | 2016 | — |
| −2 | K162071 | IllumiFlow Laser Cap | Eglobal, LLC | 2017 | — |
| −1 | K200464 | LG Pra. L Derma LD Scalp Care | Lg Electronics.Inc | 2020 | — |
| 0 (this device) | K210169 | Hair Growth Device | Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd. | 2021 | — |
| +1 | K222477 | Hair Growth Device | Dongguan Lescolton Medical Equipment Co., Ltd. | 2022 | — |
| +1 | K231153 | Neuhat Hair Growth System; ibeauty.com Laser Cap | Nature, Inc.redible, Inc. | 2023 | — |
| +2 | K262183 | Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126… | Shenzhen Nuon Medical Equipment Co., Ltd. | 2026 | — |
| +2 | K251017 | CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025 | — |
| +1 | K242747 | FAQ™ (302) | Foreo, Inc. | 2024 | — |
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 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K200464 | LG Pra. L Derma LD Scalp CareSummary page 4…p Common Name: Laser, Comb, Hair Regulatory Class: Class II Product Code: OAP Review Panel: General & Plastic Surgery 4. The Predicate Devices Primary Predicate: K200464 LG Pra.L Derma LD Scalp Care Secondary Predicate: Kl51662 iRestore Hair Growth System 5. Device Description === Page 5… | 2020 |
| * | K151662 | iRestoreSummary page 6…oposed Device Primary Predicate Secondary Predicate 510k number K200464 K151662 Proprietary LG Pra.L Derma LD iRestore Hair Growth… | 2016 |
What descends from it? (6)
3 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 14 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K222477 (Dongguan Lescolton Medical Equipment Co., Ltd., 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K200464.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
The Hair Growth Device is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210169: Hair Growth Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210169
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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