# K974468: Photonic Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Bales Scientific, Inc.
- Decided: Jun 22, 1998 after 208 days
- Product code: ILY (Lamp, Infrared, Therapeutic Heating)
- 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.
215 later devices descend from it; 4 cite it directly.
0 of 216 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
- K032229: Quantum Warp 10 Light Delivery System (2003), 198 descendants of its own
- K043317: Omnilux Plus (2005), 171 descendants of its own
- K050216: Omnilux Revive and Omnilux Plus (2005), 160 descendants of its own
- K060792: Illumimed (2006), 115 descendants of its own
- K083183: Aklarus Phototherapy System (2009), 91 descendants of its own

## Indications for use
The Photonic Stimulator emits infrared light that penetrates the skin to promote increased blood flow and circulation, thereby providing safe, temporary relief of minor aches and pains where heat is indicated.

Source page: https://510kreport.com/device/K974468
Methodology: https://510kreport.com/methodology