510(k) · Cleared
ClearedBosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · OAP Laser, Comb, Hair
Cleared on Jan 29, 2020 as substantially equivalent to K162071 (Eglobal, LLC, 2017) and 8 other predicates after a 132-day review. Its family tree reaches back 8 generations to 2007. 3 later devices descend from it.
- Decided
- Jan 29, 2020
- Review
- 132 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 8 generations to K060305 (2007). 25 ancestors in all, the oldest K001179 (2000). 3 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK060305 Hairmax LasercombLexington International, LLC · 2007
- 7 generations backK093499 Hairmax LasercombLexington International, LLC · 2009
- 6 generations backK103368 Hairmax LasercombLexington International, LLC · 2011
- 5 generations backK142573 HairMax LaserComb, HairMax LaserCombLexington International, LLC · 2014
- 4 generations backK160285 Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Capillus, LLC · 2016
- 3 generations backK162071 IllumiFlow Laser CapEglobal, LLC · 2017
- 2 generations backK171895 Grivamax Hair Growth SystemLeana Orders, Inc. · 2017
- 1 generation backK181253 Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser CupPjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · 2018
- This deviceK192585 Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser CapPjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · 2020
- Descendant · cites it directly · 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 · 2 generations on · 0 of its ownK261675 CHZL Red Light Therapy Hair Growth Cap (Model…Shenzhen Chuanghong Zhilian Technology 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
Most influential descendants
Showing 3 of 3 · See all- 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 · cites it directly2descendants
- K261675CHZL Red Light Therapy Hair Growth Cap (Model…Shenzhen Chuanghong Zhilian Technology 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K060305 | Hairmax Lasercomb | Lexington International, LLC | 2007 | — |
| −7 | K093499 | Hairmax Lasercomb | Lexington International, LLC | 2009 | — |
| −6 | K103368 | Hairmax Lasercomb | Lexington International, LLC | 2011 | — |
| −5 | K142573 | HairMax LaserComb, HairMax LaserComb | Lexington International, LLC | 2014 | — |
| −4 | K160285 | Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202 | Capillus, LLC | 2016 | — |
| −3 | K162071 | IllumiFlow Laser Cap | Eglobal, LLC | 2017 | — |
| −2 | 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 | — |
| 0 (this device) | 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 | — |
| +2 | K261675 | CHZL Red Light Therapy Hair Growth Cap (Model… | Shenzhen Chuanghong Zhilian Technology Co., Ltd. | 2026 | — |
| +2 | 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 |
|---|---|---|
| 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? (9)
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…hoenix Medical Technology, LLC 1499 Northwest 79th Av., Miami, FL 33126 Telephone: (305)477-2515 Predicate Devices: Illumiflow Laser Cap (K162071)—Cleared for OTC use; Theradome LH80 PRO (K122950)—Cleared for OTC use; Capillus 272, 202 and 82 LLLT Devices (K143199; K150578;… | 2017 |
| * | K122950 | Laser HelmetSummary page 4…1499 Northwest 79th Av., Miami, FL 33126 Telephone: (305)477-2515 Predicate Devices: Illumiflow Laser Cap (K162071)—Cleared for OTC use; Theradome LH80 PRO (K122950)—Cleared for OTC use; Capillus 272, 202 and 82 LLLT Devices (K143199; K150578; K151516; K153618; K163170 and K160285) Reference… | 2013 |
| * | K143199 | Capillus 272 ProSummary page 4…7-2515 Predicate Devices: Illumiflow Laser Cap (K162071)—Cleared for OTC use; Theradome LH80 PRO (K122950)—Cleared for OTC use; Capillus 272, 202 and 82 LLLT Devices (K143199; K150578; K151516; K153618; K163170 and K160285) Reference Devices: iGrow-II Hair Growth System (K122248; K140931, additional in… | 2015 |
| * | K150578 | Capillus 272 Office ProSummary page 4…Predicate Devices: Illumiflow Laser Cap (K162071)—Cleared for OTC use; Theradome LH80 PRO (K122950)—Cleared for OTC use; Capillus 272, 202 and 82 LLLT Devices (K143199; K150578; K151516; K153618; K163170 and K160285) Reference Devices: iGrow-II Hair Growth System (K122248; K140931, additional indication… | 2015 |
| * | K151516 | Capillus82Summary page 4…e Devices: Illumiflow Laser Cap (K162071)—Cleared for OTC use; Theradome LH80 PRO (K122950)—Cleared for OTC use; Capillus 272, 202 and 82 LLLT Devices (K143199; K150578; K151516; K153618; K163170 and K160285) Reference Devices: iGrow-II Hair Growth System (K122248; K140931, additional indication for use i… | 2015 |
| * | K153618 | Capillus202Summary page 4…: Illumiflow Laser Cap (K162071)—Cleared for OTC use; Theradome LH80 PRO (K122950)—Cleared for OTC use; Capillus 272, 202 and 82 LLLT Devices (K143199; K150578; K151516; K153618; K163170 and K160285) Reference Devices: iGrow-II Hair Growth System (K122248; K140931, additional indication for use in females… | 2016 |
| * | K163170 | Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312…Summary page 4…low Laser Cap (K162071)—Cleared for OTC use; Theradome LH80 PRO (K122950)—Cleared for OTC use; Capillus 272, 202 and 82 LLLT Devices (K143199; K150578; K151516; K153618; K163170 and K160285) Reference Devices: iGrow-II Hair Growth System (K122248; K140931, additional indication for use in females; K141567… | 2017 |
| * | K160285 | Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Summary page 4…p (K162071)—Cleared for OTC use; Theradome LH80 PRO (K122950)—Cleared for OTC use; Capillus 272, 202 and 82 LLLT Devices (K143199; K150578; K151516; K153618; K163170 and K160285) Reference Devices: iGrow-II Hair Growth System (K122248; K140931, additional indication for use in females; K141567, original c… | 2016 |
| * | K181253 | Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser CupSummary page 10…me laser wavelength, output power (per diode), output beam, energy type, laser field, and treatment area as the Bosley Revitalizer 272 and 164 Laser Caps cleared under K181253. Total “dose” – delivered energy over time – (J/cm ²) is reduced due to the reduced number of laser diodes. However, since the c… | 2018 |
| † | K122248 | Igrow II Hair Growth System | 2012 |
| † | K140931 | Igrow II Hair Growth System | 2014 |
| † | K141567 | Igrow - II Hair Growth System, Igrow Hair Growth System | 2014 |
| † | K142573 | HairMax LaserComb, HairMax LaserComb | 2014 |
| † | K171895 | Grivamax Hair Growth System | 2017 |
| † | K162782 | iHelmet Hair Growth System | 2017 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240456 | Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap | 2024 | 2 |
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 5 companies; a new generation was cleared every 1.4 years on median.
- None of the 25 ancestors has a recall.
- Of its descendants, K240456 (Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC, 2024) has gone furthest, with 2 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 Bosley Revitalizer 96 Laser Cap is 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/K192585 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192585: Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192585
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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