# K090724: OR-Light

- Pathway: 510(k) (Traditional)
- Applicant: Yperion Technology
- Decided: Oct 7, 2009 after 202 days
- Product code: ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect)
- 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
Longest line of descent: 10 generations back to K910422 (1992). 64 ancestors in all.
No later device cites it as a predicate yet.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030480: L600 Hair Removal, A&M Technology (2003) Summary page 1.
- K060516: Ellipse 12PL, Model 9ESL7228, Danish Dermatologic Development A/S (2006) Summary page 1.

## Indications for use
The Or-Light® is a non-coherent light-based device intended to carry out dermatologic and aesthetic care. It is meant to be handled by competent professionals trained in intense pulsed light technology. Two different applicators can be used on the Or-Light® device. The HR applicator (610-1000 nm) is indicated for: Hair Removal for skintype I to IV The SR applicator (400-1000 nm) is indicated for Benign pigmentary lesions for skintype I to III Benign vascular lesions for skintype I to III Inflammatory acne treatment for skintype I to III

Source page: https://510kreport.com/device/K090724
Methodology: https://510kreport.com/methodology