# K041565: Lazrpulsr 4X

- Pathway: 510(k) (Traditional)
- Applicant: Led Healing Light, LLC
- Decided: Mar 3, 2005 after 266 days
- Product code: NHN (Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy)
- 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.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K081141: Combocare 2000 (2008), 6 descendants of its own
- K083202: Combocare 2000 (2008), 2 descendants of its own
- K083822: Laser Touchone (2009), 1 descendant of its own
- K160246: SimulCare II (TM) (2016), 0 descendants of its own
- K142025: Neurolumen PN-1000 (2015), 0 descendants of its own

## Indications for use
The Lazr Pulsr 4x is a non-heating lamp, infrared as described under the provisions of 21 CFR 890.5500 and is indicated for: Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

Source page: https://510kreport.com/device/K041565
Methodology: https://510kreport.com/methodology