Winkonlaser FE60: FDA 510(k) Clearance K253790
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At Winkonlaser, we do not expect a clinic to take the word FDA cleared at face value. When someone asks about our EMS sculpt machines, we give the K-number first. For the FE60, that number is K253790. Beijing Winkonlaser Technology Limited received FDA 510(k) clearance under K253790 for the High Intensity Focused Electromagnetic Stimulation Device, the FE60. This page explains what that clearance covers, what it does not cover, and how to verify it.
Summary: What the clearance says
The short answer is yes. Our FE60 has a traceable FDA 510(k) clearance. The K253790 record lists it as a Class II powered muscle stimulator for muscle conditioning under product code NGX, with a decision date of August 13, 2026 and Beijing Winkonlaser Technology Limited as the applicant. That is the part any buyer can verify in the FDA database.
What the clearance does and does not cover is the part that matters for a purchase decision:
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Covers: our FE60 as a powered muscle stimulator for muscle stimulation and muscle conditioning.
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Does not cover: fat reduction, fat freezing, or cryolipolysis as cleared indications.
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Is not: an FDA approval. 510(k) clearance is based on substantial equivalence to an existing device.
What K253790 actually covers
A 510(k) is a premarket notification that lets FDA clear a device after the applicant shows it is substantially equivalent to a device already on the market. For our FE60, K253790 is classified as Class II and assigned product code NGX, which FDA describes as a powered muscle stimulator for muscle conditioning. The decision date is August 13, 2026, and the listed applicant is Beijing Winkonlaser Technology Limited.
In practice, that means our FE60 is cleared for the muscle stimulation use described in the record. It is not a blanket clearance for every claim or every model. On our FE60 product page, we describe the system as a HIEMT, EMS, and RF platform with 15 Tesla energy, 5000W power, and a 1 to 135 Hz frequency range. Read those product figures as the commercial specification, not as part of the K253790 intended use.
Muscle conditioning, not fat reduction
The boundary that matters here is that K253790 is a powered muscle stimulator clearance. It supports our FE60 muscle conditioning intended use, not a fat reduction or cryolipolysis use. Our FE60 product page lists muscle build, burn fat, and skin tightening together as treatment outcomes. Those are separate commercial descriptions, not one combined FDA indication.
Our FDA 510(k) clearance for muscle stimulation does not turn a fat reduction statement into an FDA cleared fat reduction claim. If subcutaneous fat is the result you market to clients, check the device classification for that specific use in your country instead of leaning on the muscle stimulator clearance.
How to verify the clearance
We encourage buyers to start with the FDA 510(k) database. Enter K253790 and check three things: the applicant is Beijing Winkonlaser Technology Limited, the device name matches the FE60, and the product code is NGX. A K-number that belongs to a different model or a different company does not help you.
Cleared under 510(k) is also not the same as approved. 510(k) clearance is based on substantial equivalence, while approval is a separate, stricter pathway for some devices. Facility registration is different again; paying the annual registration fee does not give a device clearance.
We also recommend comparing our Winkonlaser certifications page with the model number in your written quote. If the two do not match, hold the order until we explain the mismatch.
Sibling models and exact documentation
We make the EMS sculpt series, including FE60, FE90, FE80, and FE30, as sharing the same core technology with exterior design differences. If you plan to buy one of the sibling models, ask us for the documentation tied to that exact model before you rely on it.
In my experience handling our EMS sculpt line, a certificate that covers one model can be handed over as if it covered the whole series. A K-number that belongs to the FE60 should not be copied onto an FE90 quote unless we can show the exact model documentation for the FE90.
Contraindications and honest limits
A powered muscle stimulator is not suitable for everyone. Do not use our FE60 on anyone with an implanted electronic device such as a pacemaker or defibrillator, on anyone who is pregnant, or on an area with a tumor, active skin infection, or unexplained swelling. Seizure disorders and metal implants near the treatment area also need medical clearance before treatment.
These are standard precautions for electromagnetic muscle stimulation, and they are part of why we ask buyers to match the clearance to the exact model rather than relying on a general company certificate.
What to request before you buy
We were founded in Beijing in 2012, export to 120+ countries, and have 15+ engineers. Our EMS sculpt line carries a two-year warranty on the main unit and handpiece with lifetime technical support. Before you commit, ask us to put the following in writing: the exact model number, the K-number tied to that model, the intended use language from the clearance, the warranty term, and the lead time for spare handles and the pelvic floor chair.
For a broader look at the category, see our article on whether EMS body sculpting machines work and our guide on how to choose an EMS sculpting machine.
FAQ
Q: Does the Winkonlaser FE60 have FDA clearance?
A: Yes. Our FE60 received FDA 510(k) clearance under K253790 for the High Intensity Focused Electromagnetic Stimulation Device as a Class II powered muscle stimulator for muscle conditioning with product code NGX.
Q: What use does K253790 cover?
A: Our K253790 record covers the muscle stimulation and muscle conditioning intended use. It does not cover fat reduction or cryolipolysis as a cleared indication.
Q: Are the FE90, FE80, and FE30 covered by the same clearance?
A: We make these EMS sculpt models as sharing the same core technology as the FE60 with exterior design differences. Confirm the exact model documentation before you depend on the clearance for a sibling model.
Q: Is 510(k) cleared the same as FDA approved?
A: No. 510(k) clearance is based on substantial equivalence to an existing device. Approval is a separate pathway used for some higher-risk devices.
Q: How do I check the K253790 record myself?
A: Search K253790 in the FDA PMN database and confirm the applicant, device name, and product code NGX all match your model.
Q: Does the muscle stimulator clearance make the fat reduction claims FDA cleared?
A: No. Our clearance applies to muscle stimulation. Any fat reduction statement must meet the regulatory rules for that use in your market, and we do not present it as part of the K253790 clearance.
Get the FE60 clearance documentation
To match the K253790 record to the exact FE60 or EMS sculpt model you are quoting, contact us with your model number and target market and ask for the clearance documentation and written configuration.
