In a major milestone for the professional skincare company, Dermalogica PRO’s PRO Pen Microneedling System has secured FDA 510(k) clearance as a Class II medical device, paving the way for US marketing and distribution beginning in 2026.
A turning point for Dermalogica
While Dermalogica is widely known for its professional skincare products and educational programs, this approval represents the brand’s formal entry into the medical device arena. The company positions this milestone as an evolution of its mission: bridging cosmetic skincare and clinical-grade treatments.
‘Dermalogica has always advanced skin health, but FDA clearance marks our evolution into a new arena as a medical device innovator,’ said Aurelian Lis, CEO of Dermalogica, in a statement. ‘By moving beyond traditional skincare and bringing our innovation mindset into medical aesthetics, we’re not just celebrating a brand milestone – we’re raising the bar for the entire industry with treatments practitioners are proud to deliver and consumers can truly trust.’
Key technical details
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The FDA determined that the PRO Pen is substantially equivalent to legally marketed predicate devices, enabling its clearance.
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The PRO Pen has been classified under regulation 21 CFR 878.4430, the standard for microneedling devices for aesthetic use.
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According to the FDA summary, the PRO Pen is intended to improve the appearance of facial acne scars in adults aged 22 years and older.
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Some of the enhancements over predicate devices include:
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Dual power options (rechargeable battery or direct AC adapter)
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Adjustable needle depth settings in 0.2 mm increments, up to 1.5 mm
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A longer shelf life for the sterile 14-pin cartridges (3 years vs. 2 years)
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The device underwent rigorous nonclinical and clinical testing, including evaluations of needle depth accuracy, sterility, fluid ingress prevention, electrical safety, cytotoxicity and human patch testing for irritation or sensitisation.
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The PRO Pen must adhere to all general regulatory controls (eg, device listing, labelling, quality system regulations, adverse event reporting) and is subject to FDA’s oversight post-market.
The PRO Pen’s combination of precision control, safety features and integration with Dermalogica PRO skincare products (eg, ‘nanofusion’ for enhanced serum delivery) positions it well to compete in a crowded microneedling space. For clinics, the arrival of a new FDA-cleared microneedling tool from a recognisable skincare brand may lower entry barriers and expand consumer interest in in-office skin treatments.
