# K051537: Hilt Family Laser: Hilt I, Hilt II, Hilt Iii

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Sep 26, 2005 after 108 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
No predicates in its family tree.
47 later devices descend from it; 2 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MLT-1000 IR Laser System: named in the summary without a submission number

## Most influential descendants
- K123971: Cynosure 1064NM Diode Laser (2013), 25 descendants of its own
- K150724: SculpSure (2015), 21 descendants of its own
- K150230: SculpSure (2015), 21 descendants of its own
- K160470: SculpSure (2016), 20 descendants of its own
- K141861: Hilthera 4.0 (2015), 20 descendants of its own

## Indications for use
The HILT Family Laser is intended to provide topical heating for the purpose of elevating tissue temperature for the 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/K051537
Methodology: https://510kreport.com/methodology