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Devices & Tech

VIOL Scarlet Pro Wins FDA 510(k) Clearance

RF microneedling device clears with SB-49TIP technology—another entrant in a crowded RF space.

Image: Inside MedSpa

VIOL Medical has secured FDA 510(k) clearance for the Scarlet Pro, an RF microneedling device featuring SB-49TIP technology. The clearance positions VIOL as a competitor in the RF microneedling segment dominated by Morpheus8, Secret RF, and Genius.

RF microneedling has become a workhorse procedure for practices seeking to address skin texture, laxity, and post-inflammatory hyperpigmentation—especially in the post-GLP-1 body-contouring surge. The market is crowded, but differentiation through needle-tip design, energy delivery, and ergonomics can capture share from practices seeking alternatives or redundancy in their device portfolio.

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RF microneedling device clears with SB-49TIP technology—another entrant in a crowded RF space.

The SB-49TIP designation suggests a novel needle-tip geometry that may improve efficacy or patient comfort. For practice owners, this clears another option for RF microneedling procurement, though adoption hinges on clinical outcomes, pricing, and lease/purchase terms relative to incumbents.

Source: original report ↗

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