510(k) · Cleared
ClearedBosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup
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 Aug 10, 2018 as substantially equivalent to K162071 (Eglobal, LLC, 2017) and 3 other predicates after a 91-day review. Its family tree reaches back 7 generations to 2007. 4 later devices descend from it.
- Decided
- Aug 10, 2018
- Review
- 91 days
- Class
- Class II
- Product code
- OAP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K060305 (2007). 18 ancestors in all, the oldest K001179 (2000). 4 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK060305 Hairmax LasercombLexington International, LLC · 2007
- 6 generations backK093499 Hairmax LasercombLexington International, LLC · 2009
- 5 generations backK103368 Hairmax LasercombLexington International, LLC · 2011
- 4 generations backK142573 HairMax LaserComb, HairMax LaserCombLexington International, LLC · 2014
- 3 generations backK160285 Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Capillus, LLC · 2016
- 2 generations backK162071 IllumiFlow Laser CapEglobal, LLC · 2017
- 1 generation backK171895 Grivamax Hair Growth SystemLeana Orders, Inc. · 2017
- This deviceK181253 Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser CupPjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · 2018
- Descendant · cites it directly · 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 · 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 4 of 4 · See all- K192585Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser CapPjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · 2020 · cites it directly3descendants
- 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 |
|---|---|---|---|---|---|
| −7 | K060305 | Hairmax Lasercomb | Lexington International, LLC | 2007 | — |
| −6 | K093499 | Hairmax Lasercomb | Lexington International, LLC | 2009 | — |
| −5 | K103368 | Hairmax Lasercomb | Lexington International, LLC | 2011 | — |
| −4 | K142573 | HairMax LaserComb, HairMax LaserComb | Lexington International, LLC | 2014 | — |
| −3 | K160285 | Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202 | Capillus, LLC | 2016 | — |
| −2 | K162071 | IllumiFlow Laser Cap | Eglobal, LLC | 2017 | — |
| −1 | K171895 | Grivamax Hair Growth System | Leana Orders, Inc. | 2017 | — |
| 0 (this device) | 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 | — |
| +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 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (4)
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…r Cap Product Code: OAP Regulation Number: 21 CFR 890.5500 Panel: General and Plastic Surgery Class: II (performance standards) Predicate Devices: Illuniflow Laser Cap (K162071)—Cleared for OTC use; Grivamax Hair Growth System (K171895)-Cleared for OTC use; Theradome LH80 PRO (K122950)—Cleared for OTC use… | 2017 |
| * | K171895 | Grivamax Hair Growth SystemSummary page 4…Panel: General and Plastic Surgery Class: II (performance standards) Predicate Devices: Illuniflow Laser Cap (K162071)—Cleared for OTC use; Grivamax Hair Growth System (K171895)-Cleared for OTC use; Theradome LH80 PRO (K122950)—Cleared for OTC use; Capillus 272 Pro (K143199) — original clearance for use i… | 2017 |
| * | K122950 | Laser HelmetSummary page 4…ormance standards) Predicate Devices: Illuniflow Laser Cap (K162071)—Cleared for OTC use; Grivamax Hair Growth System (K171895)-Cleared for OTC use; Theradome LH80 PRO (K122950)—Cleared for OTC use; Capillus 272 Pro (K143199) — original clearance for use in females; K160285 — adds treatments for males to… | 2013 |
| * | K143199 | Capillus 272 ProSummary page 4…w Laser Cap (K162071)—Cleared for OTC use; Grivamax Hair Growth System (K171895)-Cleared for OTC use; Theradome LH80 PRO (K122950)—Cleared for OTC use; Capillus 272 Pro (K143199) — original clearance for use in females; K160285 — adds treatments for males to the indications for use of all Capillus models)… | 2015 |
| † | 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 |
What descends from it? (4)
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 11 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K192585 (Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC, 2020) has gone furthest, with 3 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. 2018, 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 272 and 164 Laser Caps 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-3, or frontal; both with Fitzpatrick Skin
Types I to IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181253: Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181253
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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