510(k) · Cleared
ClearedGrivamax Hair Growth System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Leana Orders, Inc. · OAP Laser, Comb, Hair
Cleared on Aug 22, 2017 as substantially equivalent to K162071 (Eglobal, LLC, 2017) after a 57-day review. Its family tree reaches back 6 generations to 2007. 6 later devices descend from it.
- Decided
- Aug 22, 2017
- Review
- 57 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. 6 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 deviceK171895 Grivamax Hair Growth SystemLeana Orders, Inc. · 2017
- Descendant · cites it directly · 4 of its ownK181253 Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser CupPjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · 2018
- Descendant · 2 generations on · 3 of its ownK192585 Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser CapPjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · 2020
- Descendant · 2 generations on · 2 of its ownK240456 Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley…Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · 2024
- Descendant · 3 generations on · 0 of its ownK261675 CHZL Red Light Therapy Hair Growth Cap (Model…Shenzhen Chuanghong Zhilian Technology 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 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K181253Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser CupPjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · 2018 · cites it directly4descendants
- K192585Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser CapPjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · 2020 · 2 generations on3descendants
- K240456Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser CapPlm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · 2024 · 2 generations on2descendants
- K261675CHZL Red Light Therapy Hair Growth Cap (Model…Shenzhen Chuanghong Zhilian Technology Co., Ltd. · 2026 · 3 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) | K171895 | Grivamax Hair Growth System | Leana Orders, Inc. | 2017 | — |
| +1 | 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 | — |
| +2 | 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 | — |
| +3 | K261675 | CHZL Red Light Therapy Hair Growth Cap (Model… | Shenzhen Chuanghong Zhilian Technology 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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 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 5…data was produced for this submission because the Grivamax Hair Growth System is the same device as the predicate, the Illumiflow Laser Cap, cleared under K162071. Both the Grivamax Hair Growth System and Illumiflow Laser Cap are the IDENTICAL same device offered for PRIVATE LABEL by… | 2017 |
What descends from it? (6)
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 10 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K181253 (Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC, 2018) has gone furthest, with 4 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. 2017, 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 GrivaMax Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications Ha-V and for both, Fitzpatrick Classification of Skin Phototypes of 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/K171895 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171895: Grivamax Hair Growth System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171895
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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