# K251684: Alma TED+ System

- Pathway: 510(k) (Traditional)
- Applicant: Alma Lasers, Inc.
- Decided: Jun 5, 2026 after 368 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: 4 generations back to K060305 (2007). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230134: Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002, Hubei Yjt Technology Co.,Ltd (2023) Summary page 5.

## Indications for use
Alma TED+ System is indicated to treat Androgenetic Alopecia and promote hair growth infemales who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss and in males who have Norwood Hamilton Classifications of IIa to V and who both have Fitzpatrick SkinTypers I-IV.

Source page: https://510kreport.com/device/K251684
Methodology: https://510kreport.com/methodology