Aesthetic Laser Certifications Explained

Three certification concepts, at general level

Three certification concepts appear most often in aesthetic laser equipment: CE marking under the European medical device framework, FDA 510(k) clearance in the United States, and ISO 13485 quality management for medical devices. In general terms, CE marking indicates conformity with applicable European requirements, FDA 510(k) is a premarket notification route in which a manufacturer demonstrates substantial equivalence to a legally marketed device, and ISO 13485 is a quality management standard for organizations involved in medical devices. Those are general concept descriptions; they are not claims about any specific product on this site.

Certificates for these models

Certificate registrations for these models are listed on the certifications page. Registration numbers and issuing bodies are listed on the certifications page. For any certificate your market requires, ask for the certificate document itself and check it before you order. Certificates available upon request.

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