Certifications

Certificates for the listed models

Find your model's certificate registration below. Certificates are available upon request: ask for the certificate document for your market and check it before you order.

Item	Detail page specification
FDA 510(k), as listed on the company's certifications page	K241860, Class II medical device, regulation 21 CFR 878.4810, market United States, covering AresLite DM60 and AresLite DM40P as listed.
CE MDD 93/42/EEC, as listed on the company's certifications page	Nine registrations as listed: Long Pulse Laser ENC231217GZ52 (CL300); Picosecond Laser ENC231217GZ53 (EL950, EL400); Cryolipolysis ENC231217GZ54 (HS1000C); EMS Sculpting (HIEMT) ENC231217GZ55 (FE60, plus EMC ZKT-2020050602C); IPL Multifunction ENC231217GZ56 (ML600); Cold Plasma ENC2511116GZ91 (Cold Plasma Machine, no model name); HIFU ENC231217GZ57 (HU700); CO2 Fractional Laser ENC231217GZ58 (FC300); 808nm Diode Laser ENC231217GZ59 (DM60, DM40P, plus EMC ENC231216GZ81-1). The certifications page names ENC Lab as the notified body, as listed.
ISO 13485:2016, as listed on the company's certifications page	Issuing body Avuiso Certification as listed, scope design and manufacture of aesthetic laser and energy-based medical devices, covering a list of 11 products including TM80.
IEC 60601-1 (Ed. 3.1), as listed on the company's certifications page	CB Scheme (IECEE); CB test report and certificate available upon request.