Certifications
Read this first: listed, not independently verified
Everything on this page that names a certificate, a registration number or an issuing body is quoted from the company's own certifications page, and it has not been independently verified by this site. The company states on its certifications page that its certificates are independently verifiable; this site has not checked the databases named there, so no certificate on this page is presented as a verified fact. If your market requires a certificate, ask for the certificate document itself and check it before you order. Certificates available upon request.
What the company's certifications page lists
| 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. Not independently verified. |
| 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. Not independently verified. |
| 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. The certificate number itself is not given on the certifications page, so none is printed here. Not independently verified. |
| IEC 60601-1 (Ed. 3.1), as listed on the company's certifications page | CB Scheme (IECEE); the certifications page states that the CB test report and certificate are available upon request. Not independently verified. |
What is not claimed here
- No certificate is presented as verified by this site, and no certificate mapping is extended beyond the models named on the certifications page. A mapping that covers only one model is not presented as a whole-line certification.
- Models that appear only on the certifications page (DM40P, EL400, HS1000C, ML600, HU700, TM80 and the unmodelled Cold Plasma Machine) have no product pages on this site, because no detail page has been published for them, and no specifications are given for them here.
- One certificate category that appears only in a marketplace listing of certificate categories is not presented as a company certification here, because the company's certifications page does not show it.
- Certificates for which no evidence is published are covered by the general statement: certificates available upon request.
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