Loading...
FREE SHIPPING | 3-YEAR WARRANTY ON ALL MACHINES
Loading...
Every Lazzybeauty device meets the strictest international safety and quality standards. Full documentation available for regulatory and insurance purposes.
At Lazzybeauty, safety is non-negotiable. Our devices are manufactured in ISO 13485-certified facilities and undergo rigorous testing before reaching your practice. Below you’ll find our current certifications, the standards we comply with, and a product-level compliance matrix.
Need certification documents for insurance, licensing, or import? Contact us â we provide official copies within 24 hours.
| Product | Certifications |
|---|---|
| 6-in-1 Cavitation System | CEISO 13485RoHSFCC |
| Cryo Fat Freeze Machine | CEISO 13485RoHS |
| HIFU Lifting System | CEISO 13485FDARoHS |
| Diode Laser Hair Removal | CEISO 13485FDARoHSFCC |
| RF Microneedling Device | CEISO 13485RoHS |
| LED Light Therapy Panel | CEISO 13485FDARoHSFCC |
| EMS Body Sculpting | CEISO 13485RoHS |
| Hydradermabrasion Machine | CEISO 13485RoHS |
The strictest medical device regulation globally. Requires clinical evaluation, post-market surveillance, and Unique Device Identification (UDI) for all aesthetic devices sold in the EU.
Quality System Regulation governing the design, manufacture, packaging, labeling, storage, installation, and servicing of medical devices distributed in the United States.
Medical Devices Regulations requiring device licensing, establishment licensing, and mandatory problem reporting for devices sold in Canada.
Australian regulatory framework for therapeutic goods including aesthetic devices. Requires inclusion in the Australian Register of Therapeutic Goods (ARTG).
Pharmaceutical and Medical Devices Agency oversight. Japanese approval pathway for aesthetic medical devices requiring clinical data and GMP compliance.