CoolTouch CoolLipo

CoolLipo is a laser-assisted lipolysis system from New Star Lasers, which did business as CoolTouch in Roseville, California. Its laser is Nd:YAG, but it emits at 1320 nm instead of the more common 1064 nm. FDA first cleared it as the CoolTouch NS160 CoolLipo (K072751) on January 2, 2008, with the Cynosure SmartLipo as predicate. That summary describes one cabinet holding the power supply, cooling system, microcontroller and laser, with a footswitch and an optical fiber that delivers energy through a microcannula.

CoolTouch used the CoolLipo name on more than one console. The LC215 had been cleared in October 2007 (K072424) for dermatologic incision, excision and ablation, fine lines and wrinkles, back acne and atrophic acne scars, and reflux of the great and small saphenous veins. It worked through optical fibers and either a handpiece or a JouleTracker. An April 2008 clearance (K080163) added laser-assisted lipolysis to the LC215/CoolLipo, and a June 2008 clearance (K081628) covered the LC225/CoolLipo with the same 1320 nm output and the full list of uses. In March 2009 FDA cleared a CoolTouch thermal sensing handpiece accessory that shows the temperature of the treatment area.

The FDA device database shows how the names overlap. CoolTouch CoolLipo is part R7300-0042 with catalog number NS160. CoolTouch CTEV, the vein treatment version, is part R7300-0058 and also carries NS160. CoolTouch ReNew is part R7300-0055 with catalog number LC225. Read the part number and the name on the label, because CoolTouch sold the NS160 cabinet both as CoolLipo and as CTEV.

The same database shows every CoolTouch record leaving commercial distribution on September 26, 2018. That includes fiber optic catheters (some marked single use), pullback devices and cryogen cooling parts, so it is important to know which fibers, cannulas and accessories come with the unit. Buyers will ask for the label, power-on behavior, error history and any service records.