# K130996: Erchonia Emerge

- Pathway: 510(k) (Traditional)
- Applicant: Erchonia Medical, Inc.
- Decided: Sep 16, 2013 after 159 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K241057: Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) (2025), 1 descendant of its own
- K211186: Erchonia XLR8 (2021), 1 descendant of its own
- K252273: Therapy US (2025), 0 descendants of its own
- K231409: Erchonia FX-405 (2023), 0 descendants of its own

## Indications for use
The Erchonia® XLR8™ laser is indicated for the following three indications: a. adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin b. as an adjunct to liposuction procedures of the thighs, hips and stomach for reduction of pain associated with the recovery process c. temporary reduction in post-surgery pain at 24 hours after surgery following bilateral breast augmentation surgery

Source page: https://510kreport.com/device/K130996
Methodology: https://510kreport.com/methodology