510(k) · Cleared
ClearedCurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Kaiyan Medical Equipment Co., Ltd. · OAP Laser, Comb, Hair
Cleared on Jun 17, 2025 as substantially equivalent to K231153 (Nature, Inc.redible, Inc., 2023) and 1 other predicate after a 76-day review. Its family tree reaches back 10 generations to 2007.
- Decided
- Jun 17, 2025
- Review
- 76 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K060305 (2007). 31 ancestors in all, the oldest K001179 (2000). No later device cites it as a predicate yet.
- Root · 10 generations backK060305 Hairmax LasercombLexington International, LLC · 2007
- 6 generations between
- 3 generations backK181253 Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser CupPjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · 2018
- 2 generations backK192585 Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser CapPjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · 2020
- 1 generation backK240456 Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley…Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · 2024
- This deviceK251017 CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
Show all 10 generations
- Root · 10 generations backK060305 Hairmax LasercombLexington International, LLC · 2007
- 9 generations backK093499 Hairmax LasercombLexington International, LLC · 2009
- 8 generations backK103368 Hairmax LasercombLexington International, LLC · 2011
- 7 generations backK142573 HairMax LaserComb, HairMax LaserCombLexington International, LLC · 2014
- 6 generations backK160285 Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Capillus, LLC · 2016
- 5 generations backK162071 IllumiFlow Laser CapEglobal, LLC · 2017
- 4 generations backK171895 Grivamax Hair Growth SystemLeana Orders, Inc. · 2017
- 3 generations backK181253 Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser CupPjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · 2018
- 2 generations backK192585 Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser CapPjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · 2020
- 1 generation backK240456 Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley…Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · 2024
- This deviceK251017 CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K060305 | Hairmax Lasercomb | Lexington International, LLC | 2007 | — |
| −9 | K093499 | Hairmax Lasercomb | Lexington International, LLC | 2009 | — |
| −8 | K103368 | Hairmax Lasercomb | Lexington International, LLC | 2011 | — |
| −7 | K142573 | HairMax LaserComb, HairMax LaserComb | Lexington International, LLC | 2014 | — |
| −6 | K160285 | Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202 | Capillus, LLC | 2016 | — |
| −5 | K162071 | IllumiFlow Laser Cap | Eglobal, LLC | 2017 | — |
| −4 | K171895 | Grivamax Hair Growth System | Leana Orders, Inc. | 2017 | — |
| −3 | K181253 | Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup | Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC | 2018 | — |
| −2 | K192585 | Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap | Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC | 2020 | — |
| −1 | K240456 | Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288… | Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC | 2024 | — |
| 0 (this device) | 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 |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K231153 | Neuhat Hair Growth System; ibeauty.com Laser CapSummary page 6…ice Information Sponsor: Nature Incredible Inc. Trade Name: Neuhat Hair Growth System (or ibeauty.com Laser Cap) Model: NEU300, NEU180 510(k) Number: K231153 Review Panel: General & Plastic Surgery Regulatory Class: Class II Regulatory Code: OAP Regulation: 21 CFR 89… | 2023 |
| * | K240456 | Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser CapSummary page 6…Trade Name: Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap Model: 128 model, 162 model, 288 model 510(k) Number: K240456 Review Panel: General & Plastic Surgery Regulatory Class: Class II Regulatory Code: OAP Regulation: 21 CFR 89… | 2024 |
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?
- The line of descent spans 18 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- None of the 31 ancestors has a recall.
How does its category compare?
All OAP devicesOAP Laser, Comb, Hair: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 CurrentBody Skin Dual Light Hair Growth Helmet is indicated to promote hair growth in males with who have Norwood-Hamilton classifications of IIa-V or females with who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251017 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251017: CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251017
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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