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IEC 60601-1 milestone achieved for client's electrolysis medical device

Genesys congratulates its client Permanence on launching its GEMM-16 multi-needle electrolysis hair removal product in the United States in April, after reaching the key milestone of IEC 60601-1 certification. The product was designed by Genesys Electronics Design in collaboration with Skiant Holdings.

Electrolysis is a proven technology for permanent hair removal, allowing people to live a life free of unwanted hair, which can arise from a variety of factors, including hormonal imbalances, medications, gender dysphoria and hereditary factors. 

The system works by applying a negative current to each individual hair follicle using a conductive pad and up to 16 probes simultaneously. The electrical current creates a reaction that generates sodium hydroxide, killing the follicle and removing its ability to grow. An added benefit is the stimulation of collagen and elastin production, providing additional skin rejuvenation benefits.

Genesys developed the control system using electronics only, with an analogue electronics interface. The key function is the adjustment of the current level and duration for each probe.

The GEMM-16 is classified as a medical device requiring development under Genesys' ISO 13485 quality management system. A key milestone for the project came in late 2023 when the device received certification to the demanding IEC 60601-1 standard on safety and essential performance of medical devices. This series of standards covers all aspects of electrical and mechanical safety and ensures the device can deliver its medical function without creating unacceptable risks.

In this project, Genesys delivered electronics design and facilitated the IEC 60601-1 certification process. Skiant provided commercialisation strategy, project management, engineering, compliance, and manufacturing.

Further information about the product can be viewed in our case study on the project.


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