Candela Announces Health Canada Licences for Nordlys Multi-Application System and Frax Pro Device

Candela announced Health Canada licensing and the availability of the Nordlys multi-application platform, which features Selective Waveband Technology (SWT) and the dual-wavelength Frax Pro non-ablative fractional laser platform.[1-4]

The Nordlys is designed to improve treatment targeting and patient safety, as well as drive high-ROI treatments, according to a company news release. SWT technology on the device is an advancement for intense pulsed light (IPL) treatment, designed to minimize risks compared to broadband IPL.[5,6] 

“SWT filters out unnecessary light wavelengths, minimizing heat delivery to surrounding tissues. With 50% less fluence required than broadband IPL, this improves the safety profile, increases patient comfort, keeps downtime low, and enables use of multiple technologies in a single session – all without compromising results,” according to a Candela news release. “The risk of side effects like skin overheating, hypopigmentation, and scarring associated with older IPL technology are minimized.”[5,6] 

Nordlys SWT applicators can treat photo rejuvenation, vascularity, pigmentation, acne, and hair removal.[1,3] The non-ablative fractional laser applicators deliver either deep skin resurfacing and treat acne scars, surgical scars, and striae (Frax 1550); or coagulation of soft tissue, actinic keratosis and benign pigmented lesions (Frax 1940).[1,3] A Nd:YAG 1064 nm laser on the Nordlys platform addresses vascular lesions, venous lakes, port wine stains, onychomycosis (nails) and warts.[1,3]

The Frax Pro system is a stand-alone platform featuring the Frax 1550 (1550 nm) and Frax 1940 (1940 nm) non-ablative laser applicators.[2,4] The Frax Pro technology features flexible treatment parameters, including a range of scan width options, and replaceable low-cost applicator rollers that minimize treatment expense.[5]

References

1. Nordlys Health Canada Medical Device Licence (108788), January 2023. 
2. Frax 1940 for Nordlys & Frax Pro Systems, 510(k) clearance (K212492), December 2021.
3. Frax 1550 for Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra, 510(k) clearance (K161162), September 2016.
4. Frax Pro Health Canada Medical Licence (108646), December, 2022.
5. Data on File, Candela, 2023.
6. Bjerring P, et al. Lasers Surg Med. 2004;34(2):120-126.