# K240456: Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap

- Pathway: 510(k) (Special)
- Applicant: Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC
- Decided: May 22, 2024 after 97 days
- Product code: OAP (Laser, Comb, Hair)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K060305 (2007). 26 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192585: Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap, Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC (2020) Summary page 5.
- K181253: Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup, Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC (2018) Summary page 5.

## Most influential descendants
- K261675: CHZL Red Light Therapy Hair Growth Cap (Model (s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D) (2026), 0 descendants of its own
- K251017: CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K240456
Methodology: https://510kreport.com/methodology