# K221987: Erchonia GVL

- Pathway: 510(k) (Traditional)
- Applicant: Erchonia Corporation
- Decided: Sep 1, 2022 after 57 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: 2 generations back to K152196 (2016). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191257: Erchonia EVRL, Erchonia Corporation (2019) Summary page 4.

## Indications for use
The Erchonia@ GVL laser is generally indicated: a. while using the green and violet diode simultaneously, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin, b. and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.

Source page: https://510kreport.com/device/K221987
Methodology: https://510kreport.com/methodology