1,260-LED red and near-infrared belt, cleared as the Sculpt LED Belt under K260688; no battery.
$499
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Usability
Usability
The Sculpt is the one iRestore body device with a clearance: K260688, cleared in May 2026 for its maker, Shenzhen Kaiyan, under the name Sculpt LED Belt, lists the same 630, 850 and 940 nm peaks and a mains-powered version with no battery. The clearance does not print iRestore's model number or an LED count, so the trace rests on the trade name and the matching specification. At 49.6 by 6.9 inches it covers more than any other wrap scored here. It has no battery, so a session means a cord to the wall or a $99 power bank, and an Amazon owner calls that a disappointment. Amazon rates it 3.6 from 26, split 47 percent five-star against 30 percent at one or two stars. The warranty is one year, and at $499 it is $200 more than the cordless Flex.
- 510(k) K260688 is for the Sculpt LED Belt by name
- 1,260 LEDs across a 49.6 x 6.9 in wrap
- Three published peaks, 630, 850 and 940 nm
- Silicone skin-contact side
- Hands-free, with 10 to 30-minute timers
- No battery; the power bank is $99 more
- Clearance does not print iRestore's model number or an LED count
- Amazon 3.6 from 26, with 30 percent at one or two stars
- One-year warranty
- No independent output measurement
The Sculpt is a 49.6 x 6.9 in wrap belt with 1,260 LEDs in 420 tri-core chips at 630 nm red, 850 nm near-infrared and 940 nm, and a silicone skin side. It runs 10, 20 or 30-minute sessions at three brightness levels and has no battery: it runs from a USB-C wall plug, or from a $99 power bank sold separately. It weighs 1.65 lb. Its OEM, Shenzhen Kaiyan, holds 510(k) K260688 for the Sculpt LED Belt.
Additional information
Specification: iRestore Sculpt LED Belt
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