# K061470: Del Sol Blue Light Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Edge Systems Corporation
- Decided: Jul 20, 2006 after 55 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Del Sol Blue Light Therapy System is intended to provide phototherapeutic light to the body. The Del Sol Blue Light Therapy System is generally indicated to treat dermatological conditions. The Del Sol Blue Light Therapy System is specifically indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris.

Source page: https://510kreport.com/device/K061470
Methodology: https://510kreport.com/methodology