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Devices & Tech

Cynosure Gets FDA Clearance for RF Microneedling

New device expands Cynosure's energy-based portfolio for skin tightening and texture.

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INMDInMode Ltd.+1.0%

Cynosure announced FDA 510(k) clearance for a radiofrequency microneedling device, adding to its portfolio of energy-based aesthetic systems. RF microneedling combines fractional microneedle penetration with RF energy delivery, targeting collagen remodeling and skin tightening at depths typically 1.5–2.5 mm.

The market for RF microneedling is crowded. InMode's Morpheus8 and Morpheus8MAX dominate the premium segment; Cutera's Intensif and VIOL's Scarlet Pro compete on price and ease of use. Cynosure's entry signals confidence in the category's durability and suggests the company sees RF microneedling as essential to a modern device portfolio. The clearance likely covers indications for facial and body skin tightening, wrinkles, and possibly acne scarring—standard for the category.

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RF microneedling targets collagen remodeling at 1.5–2.5 mm depth.

For practices, RF microneedling offers higher per-treatment revenue than laser alone and strong patient retention when bundled with injectables. Cynosure's distribution strength through its existing channel may accelerate adoption among practices already using the company's laser platforms.

Source: original report ↗

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