DEKA HELIX

HELIX is a DEKA resurfacing system that combines an RF excited 10,600 nm CO2 laser with a 1570 nm fiber laser. The FDA cleared the DEKA HELIX under K222221 on January 4, 2023, naming the Alma Hybrid as predicate. Cartessa Aesthetics announced it in May 2023, describing it as the Tetra CO2 feature set plus a 1570 nm fiber laser and stating that the United States was the first market to sell it. Cleared uses include CO2 skin resurfacing and soft tissue surgery in dermatology and plastic surgery, and fractional resurfacing and coagulation at 1570 nm.

The clearance describes a console with touch screen, articulated arm, footswitch, non-fractional CO2 handpieces and a combined CO2 and 1570 nm fractional scanner. CO2 output reaches 70 W. The scanner covers areas up to 20 by 20 mm, with a 0.374 mm spot at 10,600 nm, a 0.75 mm spot at 1570 nm and up to 400 pixels per cm2 at 1570 nm. The cabinet measures 62 by 63 cm, stands 138 cm tall or 202 cm with the arm raised, weighs about 70 kg and runs on 100 to 230 V single phase at 16 A. DEKA lists three scanners, MATRIX DOT, SCAR 3 PRO and DERMASCAN, the last used with 4 inch and 7 inch handpieces and an integrated smoke evacuator.

CoolPeel, Sultra and Fusion are Cartessa treatment names for the CO2, the 1570 nm and the mixed modes, not hardware. Cartessa counts seven sequential and alternating mixed modes. The Tetra is the nearest relative but has no second wavelength, while DEKA's DUOGlide pairs CO2 with 1540 nm, not 1570 nm. AccessGUDID lists the DEKA HELIX as model M133A1.

Buyers will want the scanner, every CO2 handpiece and spacer, and the footswitch accounted for. Expect questions about the articulated arm mirrors, the scanner window and any service on either laser source, along with the software version. Photograph the serial label showing M133A1, the touch screen and the scanner.