# K141861: Hilthera 4.0

- Pathway: 510(k) (Traditional)
- Applicant: Jeisys Medical, Inc.
- Decided: Jan 7, 2015 after 181 days
- Product code: ILY (Lamp, Infrared, Therapeutic Heating)
- 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: 1 generation back to K051537 (2005). 1 ancestor in all.
20 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051537: Hilt Family Laser: Hilt I, Hilt II, Hilt Iii, Cynosure, Inc. (2005) Summary page 4.

## Most influential descendants
- K191554: LightWalker Laser System Family (2019), 19 descendants of its own
- K193656: SkyPulse (2020), 11 descendants of its own
- K193661: LightWalker Laser System Family (2020), 8 descendants of its own
- K202985: LightWalker Laser System Family (2021), 7 descendants of its own
- K202991: Fotona XPulse Pro Laser Platform (2021), 3 descendants of its own

## Indications for use
To provide topical heating for the purpose of elevating tissue temperature for temporary relief of muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

Source page: https://510kreport.com/device/K141861
Methodology: https://510kreport.com/methodology