Baldan Group (Italy) T-Shape 2

Vacuum/massage-based · RF + 650nm laser + vacuum + roller massage

CurrentFDA ClearedBe the first to review

What it's actually cleared for: Vacuum massager with light- and RF-induced heating — temporary cellulite-appearance/circulation family; prescription-use per GUDID

Last verified: August 6, 2026 · How we verify

New: $30k–$60k|Used: —market estimate, no email required

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Bottom line

The Italian spa channel's answer to VelaShape: RF + 650nm low-level laser + vacuum + roller massage in one ~$30k-60k platform — and it quietly cleared a real FDA 510(k) in 2023, putting it a regulatory tier above most spa-channel peers. The modality stack is legitimate and well-precedented (essentially the VelaShape recipe rebuilt); the "melts fat permanently" marketing is not. US footprint is young — distribution through Baldan's Florida arm and partners like Artemis/America Cryo — and iCRYO's adoption gives it real chain validation. Buy it for tightening/cellulite series revenue with medical-adjacent credibility, not as a CoolSculpting substitute.

Overview

Italian spa-channel contouring flagship, US via Artemis/America Cryo

How it works

The science

Capacitive/resistive RF heats dermis and subcutaneous tissue (genuine collagen-remodeling mechanism), vacuum plus motorized rollers mechanically work tissue and boost circulation/lymphatic flow, and a 650nm laser adds a low-level light component. RF-plus-vacuum-massage has the deepest evidence base in the cellulite category — consistent, modest, temporary improvements in cellulite appearance and small circumference reductions over a series. Not supported: permanent fat destruction or lasting results without maintenance. Expect visible smoothing/tightening across 6-12 sessions with honest regression over months if clients stop.

Patented tech

Baldan brands the combination as the four-technology "T-Shape method" (RF + laser + vacuum + roller vibration massage). Strip the branding and it's a well-executed multi-modality thermal + mechanical platform, not a novel mechanism.

Origin

Italy — B&M S.r.l. (Baldan Group), near Venice.

FDA & regulatory status

FDA ClearedCleared via 510(k)

What it's actually cleared for:

Vacuum massager with light- and RF-induced heating — temporary cellulite-appearance/circulation family; prescription-use per GUDID

510(k) numbers

K231092

Regulatory data is compiled from public FDA 510(k) records and may lag recent clearances. Always confirm status with the manufacturer before purchase.

Treatment economics

What practices charge

~$150-300 per session; courses of 6-12 sessions (1-2x/week) sold as $1,200-2,500 packages, plus maintenance every 1-3 months. Pricing varies widely — the US installed base is still small.

Consumables & recurring cost

Minimal — conductive gel at a few dollars per session; no per-treatment fee or subscription.

Ideal for

Best-fit practice

Wellness franchises and body-contouring studios wanting one machine covering cellulite, tightening, and lymphatic-sculpt menus — iCRYO runs it alongside Emsculpt NEO. Prescription-device status makes it a slightly heavier lift for a solo aesthetician than pure massage-class rivals, though it's sold heavily into the non-medical channel.

Compliance

Medical director & delegation

As a cleared prescription-use RF device, many states technically expect physician involvement in purchase/oversight (as with other RF body platforms), while others treat non-ablative body RF permissively — state variance is real; verify before buying without a medical director.

Contraindications & screening

Pregnancy, pacemakers/implanted electronics, metal implants in the area, active cancer, DVT, acute skin conditions, impaired sensation; standard RF screening.

Ownership

Warranty & service

~1-year warranty via Baldan Group Florida/US partners; the US service network is young — get parts availability, response times, and training commitments in writing.

Resale & used market

Very thin US used market — slow liquidity and 40-60% haircuts within a few years, though scarcity keeps askers from cratering. Watch for lookalike Asian clones muddying listings.