Health Canada Licences for Two Energy-Based Devices: The Award-Winning Nordlys Multi-Application System and Frax Pro® Device

Marlborough, Massachusetts, Feb. 28, 2023 /PRNEWSWIRE/ -- Candela Corporation, a leading global medical aesthetic device company headquartered in Marlborough, MA, today announced Health Canada licensing and availability of the Nordlys™ multi-application platform featuring Selective Waveband Technology (SWT®) and the dual-wavelength Frax Pro® non-ablative fractional laser platform.1-4

The Nordlys platform features advanced technologies designed to improve treatment targeting and patient safety, as well as drive high-ROI treatments for practice success.5  SWT technology on the device is a game-changing advancement to intense pulsed light (IPL) treatment, minimizing risks compared to broadband IPL.5,6  SWT filters out unnecessary light wavelengths, minimizing heat delivery to surrounding tissues.5 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.5-8 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 is distinguishable by its flexible treatment parameters, including a range of scan width options, and replaceable low-cost applicator rollers that minimize treatment expense.5

“Our technicians have been happy with the results of the Nordlys system, both from SWT treatments as well as the Frax 1550 resurfacing capabilities. It is easy-to-use technology. As our team becomes more comfortable with the system, we have started to explore other indications such as acne treatments with SWT and stretch marks and texture concerns with the Frax 1550 handpiece”, says Ron Brown, M.D. of True Balance Medical Spa.

“Candela is passionate about advancing the field of energy-based devices to improve procedure safety and clinical outcomes for patients. The Health Canada licences for the Nordlys and Frax Pro systems allow us to provide advanced and differentiated technologies, like SWT, to our customers in Canada,” states Geoffrey Crouse, CEO of Candela.

To learn more about the Nordlys and Frax Pro systems, please visit Nordlys and Frax Pro pages, or reach out to a Candela Sales representative today.

About Candela Corporation

Candela is a leading global medical aesthetic device company with an extensive product portfolio and a global distribution footprint. The Company's technology enables physicians to provide advanced solutions for a broad range of medical aesthetic applications including hair removal, wrinkle reduction, tattoo removal, women's health treatments, facial resurfacing, traumatic and surgical scar treatments, body contouring, improving the skin's appearance through the treatment of benign vascular and pigmented lesions, and the treatment of acne, leg veins and cellulite. Candela has a wide portfolio of trusted, leading IPL and other laser-based platforms, including Profound Matrix, Vbeam®, the Gentle Family®, Nordlys, PicoWay®, Exceed, Profound®, Profound Matrix, CO2RE®, and CO2RE Intima® systems. Acquired by Apax Partners in July 2017, the Company markets, services and supports its products in 86 countries. It has offices in the United States, Australia, Canada, China, France, Germany, Hong Kong, Israel, Italy, Japan, Portugal, Spain, the United Kingdom, as well as many international distributors.

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.
7. Nordlys User Manual, 2022.
8. Schallen KP, Murphy M. Treatment of photodamaged skin with a combined dual-filter intense pulsed light and fractional 1550-nm laser system. Lasers Surg Med Suppl. 2020;52(S32).

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