ONDA PRO in NYC: What the Clearance Covers
10 August 2026
What ONDA PRO's microwave treatment is actually cleared to do, where the industry overstates it, and what a session is like. An honest read of the indication.
ONDA PRO is not a weight loss treatment, and it is not a smaller, gentler version of surgery. Those two sentences are worth reading before anything else here, because the category this device sits in is one of the easiest in aesthetics to oversell. If the goal is to weigh less, no device does that. If the goal is what liposuction achieves, only liposuction achieves it. Everything below assumes those two sentences have been read rather than skimmed.
What the clearance actually says is specific, and it is worth knowing before you book. ONDA PRO is FDA cleared as SPECCHIO, 510(k) K260647, for heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation — and, via the massage device, a temporary reduction in the appearance of cellulite. That is the whole of the cleared indication.
What the device is, is published on our technology page: ONDA PRO is an energy platform made by El.En. and sold by DEKA that delivers 2.45 GHz microwave energy to raise the temperature of tissue below the skin's surface. The surface stays cool and protected, so the treatment is comfortable and needs no incisions and no anesthesia.
Three handpieces focus the heat at three different depths, so the treatment can be matched to the area. Many treatments take approximately 20–45 minutes depending on the area, and most patients return to normal activities immediately. The treatment is non-invasive: no incisions, no anesthesia.
What people report feeling is warmth — deep and spreading rather than sharp and surface-level — and the person treating you will ask you to describe it as they go, because your description is one of the inputs they are adjusting to. The area may look flushed and feel warm for a while, in the way skin does after any heating. You can dress and leave; nothing about the appointment requires someone to collect you. Allow around an hour for a first visit, which includes the consultation rather than just the time the handpiece is in use.
The areas our own technology page lists are Abdomen, Flanks (Love Handles), Inner Thighs, Outer Thighs, Arms, Bra Line and Knees. For the temporary reduction in the appearance of cellulite, the areas we treat are the thighs and the buttocks, where the dimpled surface most commonly appears and where the manufacturer's own clinical images document. If you ask for an area because you want it to look smaller, we will tell you that this is not what the clearance behind this device supports, and we would rather lose the booking than take it on a promise we cannot stand behind.
Suitability is a clinical judgement about you, and a website cannot make it. Bring your history and your questions to a consultation, including anything implanted, any medication you take, and anything you are unsure about. If the answer is that this platform is not the right one, we will say so. How many appointments anyone should have is a clinical judgement too, and it belongs to the person assessing you rather than to this page.
Aesthetic devices reach the American market through the FDA's 510(k) route, which establishes that a device is substantially equivalent to one already on the market. That is clearance. It is a different and lighter process than approval, and the two words are not interchangeable however often advertising treats them as if they were. We write inside the cleared indication and cite it, and our build refuses copy that reaches past it.
The clearance makes no claim about removing tissue or changing weight, and we do not print one either. Ask any clinic for the 510(k) number it relies on and read it yourself; ours is printed in full on our safety page.
The rest of our menu carries its own indications and its own words. Body Balance Ritual is a restoring full-body treatment that releases deep tension, eases tired muscles, and improves circulation. Signature Massage Therapy is a gentle, rhythmic 60-minute lymphatic drainage massage that stimulates the lymphatic system, reduces puffiness, and promotes natural detoxification. Neither is part of the ONDA PRO clearance.
Other platforms we use carry their own clearances. Morpheus8 is our radiofrequency microneedling platform, and Sofwave is our ultrasound platform. Each carries its own clearance with its own wording, and neither is a way of doing what ONDA PRO's clearance describes. Microcoring is not on our menu, so we do not offer it.
Our treatment-areas page explains how an area is photographed: standing, in good light, the same way each time, because a comparison is only worth anything if the two images were made under the same conditions. ONDA technology was first introduced in 2018 and has since become popular across Korea and Europe.
If you want to read the clearance rather than a description of it, the safety page prints the indication in full and links the 510(k) document. A consultation is where suitability is decided, and it costs you nothing.
This page was reviewed by Olivia Yang, Licensed Cosmetologist.
NY License AEC-25-00169
Reviewed: the description of this treatment, how the appointment runs, and what the studio provides — not its clinical safety or aftercare.
Last reviewed August 13, 2026.





