510(k) · Cleared
ClearedLG Pra. L Derma LD Scalp Care
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lg Electronics.Inc · OAP Laser, Comb, Hair
Cleared on Jul 23, 2020 as substantially equivalent to K162071 (Eglobal, LLC, 2017) after a 148-day review. Its family tree reaches back 6 generations to 2007. 7 later devices descend from it.
- Decided
- Jul 23, 2020
- Review
- 148 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K060305 (2007). 10 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK060305 Hairmax LasercombLexington International, LLC · 2007
- 5 generations backK093499 Hairmax LasercombLexington International, LLC · 2009
- 4 generations backK103368 Hairmax LasercombLexington International, LLC · 2011
- 3 generations backK142573 HairMax LaserComb, HairMax LaserCombLexington International, LLC · 2014
- 2 generations backK160285 Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Capillus, LLC · 2016
- 1 generation backK162071 IllumiFlow Laser CapEglobal, LLC · 2017
- This deviceK200464 LG Pra. L Derma LD Scalp CareLg Electronics.Inc · 2020
- Descendant · cites it directly · 6 of its ownK210169 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 · 2 generations on · 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 · 3 generations on · 0 of its ownK251017 CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K210169Hair Growth DeviceDongguan Lescolton Intelligent Electrical Appliance Co., Ltd. · 2021 · cites it directly6descendants
- K222477Hair Growth DeviceDongguan Lescolton Medical Equipment Co., Ltd. · 2022 · cites it directly2descendants
- K231153Neuhat Hair Growth System; ibeauty.com Laser CapNature, Inc.redible, Inc. · 2023 · 2 generations on1descendant
- 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 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K060305 | Hairmax Lasercomb | Lexington International, LLC | 2007 | — |
| −5 | K093499 | Hairmax Lasercomb | Lexington International, LLC | 2009 | — |
| −4 | K103368 | Hairmax Lasercomb | Lexington International, LLC | 2011 | — |
| −3 | K142573 | HairMax LaserComb, HairMax LaserComb | Lexington International, LLC | 2014 | — |
| −2 | K160285 | Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202 | Capillus, LLC | 2016 | — |
| −1 | K162071 | IllumiFlow Laser Cap | Eglobal, LLC | 2017 | — |
| 0 (this device) | K200464 | LG Pra. L Derma LD Scalp Care | Lg Electronics.Inc | 2020 | — |
| +1 | K210169 | Hair Growth Device | Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd. | 2021 | — |
| +1 | K222477 | Hair Growth Device | Dongguan Lescolton Medical Equipment Co., Ltd. | 2022 | — |
| +2 | 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 | — |
| +3 | K251017 | CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K162071 | IllumiFlow Laser CapSummary page 4…General & Plastic Surgery (ODE) 6.3 Technical Characteristics in Comparison to Predicate Devices Proposed Device K162071 Company LG Electronics Inc. EGlobal, LLC Product name LG Pra.L Derma LD Scalp Care… | 2017 |
| † | K140931 | Igrow II Hair Growth System | 2014 |
What descends from it? (7)
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 13 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K210169 (Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd., 2021) has gone furthest, with 6 descendants of its own.
- 6 other devices also cite its predicate K162071.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 LG Pra.L Derma LD Scalp Care is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of IIa-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/K200464 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200464: LG Pra. L Derma LD Scalp Care.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200464
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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