Freyr, a leading global Regulatory solutions and services company, announced that the organization has obtained the US Food and Drug Administration’s(US FDA) 510(k) clearance for Cocoon Medical – a Spain-based leading manufacturer of energy-based aesthetic medical devices.
Cocoon Medical approached Freyr for comprehensive Regulatory support to register their laser-based hair removal device, Elysion, with the US FDA. To ensure that the Spain-based device manufacturer compliantly enter the U.S. market, Freyr took upon the challenge of decoding and communicating regional regulatory scenario and made Cocoon Medical align with the requirements right on time. We are glad to complete thorough gap analysis of technical file, compilation of e-Submission package and responding to the agency queries. Now, with USFDA 510(k) clearance, Elysion is all set for sale in the U.S. market.
“That’s so wonderful! We feel great to see our Regulatory expertise enabling the clients cross the boundaries compliantly,” said Suren Dheenadayalan, CEO, Freyr. “Most overwhelming part in the Elysion 510(k) clearance is not just the device’s on-time U.S. market entry, but clients’ continuous trust that acknowledged Freyr’s workmanship,” added Suren.
Freyr is a leading, niche, full-service global Regulatory Solutions and Services Company supporting, Large, Medium and Small Size Global Life sciences companies, (Pharmaceutical |Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions etc. to PostApproval / Legacy Product Maintenance, Labeling, Artwork Change Management and other related functions.
Headquartered in New Jersey, USA, Freyr has regional offices across UK, Germany, UAE, Canada, Mexico, Singapore, Malaysia, South Africa, Slovenia, Austria, Sri Lanka and has Global Delivery Center in Hyderabad, India.