STORZ DUOLITH SD1 T-TOP ultra vs ELvation PiezoWave2T

Both the STORZ DUOLITH SD1 T-TOP ultra and the ELvation PiezoWave2T concentrate their energy at a focal point inside tissue, so they are built for the same clinical job and compare fairly. The STORZ DUOLITH SD1 T-TOP ultra uses electromagnetic wave generation; the ELvation PiezoWave2T uses piezoelectric. Neither publishes a purchase price, so both need a written quote. FDA records located: for the STORZ DUOLITH SD1 T-TOP ultra, PMA P080028 (Chronic proximal plantar fasciitis in adults, after six or more months of failed conservative care) and 510(k) K202112 (Diabetic foot ulcers); for the ELvation PiezoWave2T, an establishment listing only, which is not a clearance.

Specs and prices are estimates based on publicly available data as of September 2026. Confirm details with the manufacturer or seller before you buy.

Side by side

SpecificationFocusedSTORZ DUOLITH SD1 T-TOP ultraFocusedELvation PiezoWave2T
Technology
CategoryFocused systemsFocused systems
Wave generationElectromagneticcylindrical coil in the SEPIA handpiecePiezoelectricdirect focusing, no reflector
Energy fieldWhere the peak energy landsPeaks at a focal pointPeaks at a focal point
Technology as publishedFocused electromagnetic (SEPIA)Focused piezoelectric, direct focusing
Stated use or positioningNot statedAcoustic compression therapy for minor aches and painsthe US intended use, per ELvation
Energy outputPressure in bar, energy flux density in mJ/mm² and energy per pulse in mJ are different quantities. A figure in one row never stands in for another.
Energy flux densitymJ/mm²0.01–0.55 mJ/mm²with the standard SEPIA handpieceUp to 0.82 mJ/mm²on ELvation's European therapy sources
FrequencyHzNot publishedUp to 12 Hzcapped at 8 Hz at the highest intensities
Depth and treatment fieldFocal depth, penetration and focus volume measure three different things. Compare like with like.
Focal depth0–65 mmset with the stand-offs supplied20–60 mmfocal centre across the three US therapy sources
Maximum penetrationUp to 125 mm0.5 mm to 6 cmdepending on the therapy source
Applicators and handpiece
Applicators and transmittersSEPIA focused handpiece with stand-offsoptional C-ACTOR handpiece reaches 0.03–1.24 mJ/mm²F7G3, F10G10 and FBL10x5G2 therapy sourcesthe US line-up; a replacement F7G3 lists at $6,900
Handpiece lifeNot published5 million pulsesguaranteed per therapy source
Size and setup
DimensionsNot published405 × 226 × 450 mmUS control unit, W × H × D
ConfigurationTabletop T-TOP consoleoptional 10-inch touch screen; upgradeable to the DUOLITH SD1 TOWER »ultra«Control unit on a cartfoot switch; the US Starter package adds one therapy source and gel pads
Other published detailsFrequency and energy set on the handpiececoil designed for simple replacementHigh-resolution touch screenT-Burst and T-Ramp modes; gel pads set the depth in 5 mm steps
Price and buying
Purchase priceNot publicly listedNot publicly listed
Monthly leaseNot publicly listedNot publicly listed
Warranty and guaranteesNot publishedOne yearF7G3 source one year or 3 million impulses; FBL source one year or 5 million; consumables 90 days
Sales and serviceSTORZ MEDICAL America, Kennesaw, Georgiaexclusive North American distributorELvation Medical LLC, Alpharetta, Georgiaexclusive US seller; Richard Wolf assembles US units in Chicago
Regulatory recordRecord types and numbers exactly as located. A record covers one configuration and one indication, and never transfers to another product.
FDA record locatedPMA P080028 · 510(k) K202112Establishment listing onlynot a model-specific clearance
Indication as worded in the recordPMA P080028: Chronic proximal plantar fasciitis in adults, after six or more months of failed conservative care; 510(k) K202112: Diabetic foot ulcersListed as a therapeutic massager (product code ISA, Class I, exempt from 510(k)). Not a clearance, and carries no shockwave indication.
Other marks and claimsNone notedEU class IIb93/42/EEC
Our notes
Where it stands outThe strongest FDA paper trail in the reviewed set.Several interchangeable piezoelectric therapy sources, and published US prices for replacement sources.
What to checkThose records are configuration-specific and indication-specific. They are not a blanket clearance for the DUOLITH line.No 510(k), De Novo or PMA record was located. In the US it is listed as a therapeutic massager, and ELvation limits the US intended use to minor aches and pains.

9 further fields have no published figure for either machine.

STORZ DUOLITH SD1 T-TOP ultra vs ELvation PiezoWave2T: common questions

What is the difference between the STORZ DUOLITH SD1 T-TOP ultra and the ELvation PiezoWave2T?

Both the STORZ DUOLITH SD1 T-TOP ultra and the ELvation PiezoWave2T concentrate their energy at a focal point inside tissue, so they are built for the same clinical job and compare fairly. The STORZ DUOLITH SD1 T-TOP ultra uses electromagnetic wave generation; the ELvation PiezoWave2T uses piezoelectric. The STORZ DUOLITH SD1 T-TOP ultra is described as “Focused electromagnetic (SEPIA)”, the ELvation PiezoWave2T as “Focused piezoelectric, direct focusing”.

Which is cheaper, the STORZ DUOLITH SD1 T-TOP ultra or the ELvation PiezoWave2T?

Neither publishes a purchase price, so both need a written quote. Prices change and estimates are not quotes, so confirm both in writing.

Are the STORZ DUOLITH SD1 T-TOP ultra and the ELvation PiezoWave2T FDA cleared?

FDA records located: for the STORZ DUOLITH SD1 T-TOP ultra, PMA P080028 (Chronic proximal plantar fasciitis in adults, after six or more months of failed conservative care) and 510(k) K202112 (Diabetic foot ulcers); for the ELvation PiezoWave2T, an establishment listing only, which is not a clearance. A record covers one configuration and one indication, and never transfers to another model, so check it against the exact configuration you are quoted.

How do I choose between the STORZ DUOLITH SD1 T-TOP ultra and the ELvation PiezoWave2T?

Start with the clinical job, then ask both vendors for the same five things in writing: the exact model, revision, and which accessories are included at that price; contract term, APR, total payments, and the buyout option at the end; handpiece and consumable life, and what a replacement costs; warranty coverage and US service turnaround time; the exact FDA clearance number and the current labelling for the configuration being quoted.

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