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GC Aesthetics Gains CE Mark for Luna xt Anatomical Breast Implant

October 5, 2022

GC Aesthetics has gained a CE mark for its Luna xt silicone gel anatomical breast implant for use in breast augmentation and reconstructive surgery.

The implant, which features a microtextured surface and a high-performance shell, is the first breast implant to be approved under the EU’s Medical Device Regulation.

The new EU rules are “designed to improve product safety, ensuring greater openness, traceability and clinical safety evidence,” the company noted.

Dublin, Ireland-based GC Aesthetics is focused on developing aesthetic and reconstructive products for women.

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