510(k) · Cleared
ClearedBosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · OAP Laser, Comb, Hair
Cleared on May 22, 2024 as substantially equivalent to K192585 (Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC, 2020) and 1 other predicate after a 97-day review. Its family tree reaches back 9 generations to 2007. 2 later devices descend from it.
- Decided
- May 22, 2024
- Review
- 97 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K060305 (2007). 26 ancestors in all, the oldest K001179 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK060305 Hairmax LasercombLexington International, LLC · 2007
- 5 generations between
- 3 generations backK171895 Grivamax Hair Growth SystemLeana Orders, Inc. · 2017
- 2 generations backK181253 Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser CupPjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · 2018
- 1 generation backK192585 Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser CapPjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · 2020
- This deviceK240456 Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley…Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · 2024
- Descendant · cites it directly · 0 of its ownK261675 CHZL Red Light Therapy Hair Growth Cap (Model…Shenzhen Chuanghong Zhilian Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK251017 CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK060305 Hairmax LasercombLexington International, LLC · 2007
- 8 generations backK093499 Hairmax LasercombLexington International, LLC · 2009
- 7 generations backK103368 Hairmax LasercombLexington International, LLC · 2011
- 6 generations backK142573 HairMax LaserComb, HairMax LaserCombLexington International, LLC · 2014
- 5 generations backK160285 Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Capillus, LLC · 2016
- 4 generations backK162071 IllumiFlow Laser CapEglobal, LLC · 2017
- 3 generations backK171895 Grivamax Hair Growth SystemLeana Orders, Inc. · 2017
- 2 generations backK181253 Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser CupPjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · 2018
- 1 generation backK192585 Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser CapPjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · 2020
- This deviceK240456 Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley…Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · 2024
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 |
|---|---|---|---|---|---|
| −9 | K060305 | Hairmax Lasercomb | Lexington International, LLC | 2007 | — |
| −8 | K093499 | Hairmax Lasercomb | Lexington International, LLC | 2009 | — |
| −7 | K103368 | Hairmax Lasercomb | Lexington International, LLC | 2011 | — |
| −6 | K142573 | HairMax LaserComb, HairMax LaserComb | Lexington International, LLC | 2014 | — |
| −5 | K160285 | Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202 | Capillus, LLC | 2016 | — |
| −4 | K162071 | IllumiFlow Laser Cap | Eglobal, LLC | 2017 | — |
| −3 | K171895 | Grivamax Hair Growth System | Leana Orders, Inc. | 2017 | — |
| −2 | K181253 | Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup | Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC | 2018 | — |
| −1 | K192585 | Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap | Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC | 2020 | — |
| 0 (this device) | 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 | — |
| +1 | K261675 | CHZL Red Light Therapy Hair Growth Cap (Model… | Shenzhen Chuanghong Zhilian Technology Co., Ltd. | 2026 | — |
| +1 | 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 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K192585 | Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser CapSummary page 5…dical Technology, LLC 1499 Northwest 79th Av., Miami, FL 33126 Telephone: (305)477-2515 Predicate Devices: Bosley Revitalizer 96 Laser Cap (K192585)- Cleared for OTC use; Bosley Revitalizer 272 and 164 Laser Caps (K181253)- Cleared for OTC use; Reference Devices: Dongguan Les… | 2020 |
| * | K181253 | Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser CupSummary page 5…Miami, FL 33126 Telephone: (305)477-2515 Predicate Devices: Bosley Revitalizer 96 Laser Cap (K192585)- Cleared for OTC use; Bosley Revitalizer 272 and 164 Laser Caps (K181253)- Cleared for OTC use; Reference Devices: Dongguan Lescolton Hair Growth Device (K210169)- Cleared for OTC use; Nooance LED and… | 2018 |
| † | K210169 | Hair Growth Device | 2021 |
| † | K231321 | Nooance Led And Laser Helmet | 2023 |
| † | K183417 | iRestore Professional 282 | 2019 |
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 17 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- None of the 26 ancestors has a recall.
- Of its descendants, K261675 (Shenzhen Chuanghong Zhilian Technology 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. 2024, 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 Bosley Booster 128 Laser Cap, Bosley Booster 162 Laser Cap, and Bosley Booster 288 Laser Cap are indicated to
treat Androgenic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of Ila to V
patterns of hair loss and to treat Androgenic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale
I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240456 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240456: Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240456
Report an extraction error
Are you the manufacturer?
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