# K211186: Erchonia XLR8

- Pathway: 510(k) (Traditional)
- Applicant: Erchonia Corporation
- Decided: Oct 22, 2021 after 185 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
Longest line of descent: 1 generation back to K130996 (2013). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130996: Erchonia Emerge, Erchonia Medical, Inc. (2013) Summary page 4.

## Most influential descendants
- K231409: Erchonia FX-405 (2023), 0 descendants of its own

## Indications for use
The Erchonia® XI.R8 is generally indicated: a. as 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. for the temporary reduction in post-surgery pain at 24 hours after surgery following bilateral breast augmentation surgery d. as an adjunctive treatment of postoperative pain

Source page: https://510kreport.com/device/K211186
Methodology: https://510kreport.com/methodology