# K211192: Grivamax Family of Lasers, Models 272 and 148

- Pathway: 510(k) (Traditional)
- Applicant: Leana Orders, Inc.
- Decided: Jul 20, 2021 after 90 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: 7 generations back to K060305 (2007). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173678: Diode Laser Cap, Cosmo Far East Technology Limited (2018) Summary page 5.
- K171895: Grivamax Hair Growth System, Leana Orders, Inc. (2017) Summary page 5.

## Indications for use
The Grivamax Family of Lasers , Models 272 and 148 are indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II, males who have Norwood-Hamilton Classifications of Ila - V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.

Source page: https://510kreport.com/device/K211192
Methodology: https://510kreport.com/methodology