# K171895: Grivamax Hair Growth System

- Pathway: 510(k) (Traditional)
- Applicant: Leana Orders, Inc.
- Decided: Aug 22, 2017 after 57 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: 6 generations back to K060305 (2007). 10 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162071: IllumiFlow Laser Cap, Eglobal, LLC (2017) Summary page 5.

## Most influential descendants
- K181253: Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup (2018), 4 descendants of its own
- K192585: Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap (2020), 3 descendants of its own
- K240456: Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap (2024), 2 descendants of its own
- 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 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.

Source page: https://510kreport.com/device/K171895
Methodology: https://510kreport.com/methodology