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Actually, the portable part is a bit misleading—it's 20kg, so you're not exactly tossing it in a carry-on, but it does have wheels and fits under a salon table well enough for most setups we've seen in high-turnover clinics.
What it does well is hit the compliance requirment for US and EU markets without needing a ton of extra paperwork; ISO13485 and FDA certs are already on file, so your import docs are basically just the standard TDS and SDS with the COA, and we usually have stock ready to ship in about 20 days or so.
The 4 MHz frequency with 11mm depth is better than most budget units for lifting work, but it's not suited for deep body contouring—if your buyers are all about fat reduction on the abdomen, they'd want a 2 MHz or lower, but for face and neck it's fine, and the 8mm and 13mm probes cover the usual range.
Screen size is 12 inches, which is actually a bit small for some operators I've talked to, but the ABS shell keeps the weight down and the cooling range form -5°C to +15°C (usually 2-4 weeks lead time on the cooling module, so check stock first) means you won't have overheating issues during back-to-back sessions.
Electricity demand is 100-220V, 50/60Hz—pretty much universal, so no transformer headaches for US or UK plugs—and the warranty runs 2 years, which is standerd for this price bracket, but we've had good luck with the probes lasting around 300 treatments each before needing replacement.
Anyway, for a salon looking to offer HIFU without the capital outlay of a fixed insallation, this hits the right balance of portability and cert compliance; I've ordered 15 units to test with three clinics in teh EU, and we'll see how they hold up over the first quarter.
It's ISO13485 and FDA certified, so it meets the quality standards for medical devices. That should help with getting it approved in most markets.
Yes, we offer OEM/ODM service. You can get custom probe sizes beyond the standard 8mm and 13mm, and we can also adjust the screen interface and branding to match your salon line.
MOQ starts at 10 units for OEM orders. Lead time is around 15-20 working days after sample approval, depending on customization complexity.
Yes, the warranty covers the whole machine including the cooling system and probes. If anything fails under normal use within 2 years, we'll replace or repair it free of charge.
Keep it in a dry, cool place away from direct sunlight. Since it's portable at 20kg, you can easily move it, but avoid moisture to protect the ABS casing and electronics.
