Classys Ultraformer III

The Ultraformer III is a high intensity focused ultrasound system from Classys, sold in Korea as Shurink. Classys released it in August 2014 and obtained CE certification in Europe in March 2015. It followed the original Ultraformer, approved in Korea in 2012, and was joined by the Ultraformer MPT in January 2022. Classys's 2022 annual report says the company positioned the Ultraformer III for the budget market and the MPT for the premium market.

Classys describes the system as a HIFU surgical device that coagulates tissue for eyebrow lifting, and its Korean labeling also covers tightening and improving the elasticity of skin and subcutaneous tissue in the cheeks, abdomen and thighs. It uses dual handpieces and six color coded cartridges, each set for a different focal depth. The 2022 annual report lists cartridge types L4-4.5, L7-3.0, L7-1.5, MF2, MF6, MF9 and MF13, depths of 1.5, 2.0, 3.0, 4.5, 6.0 and 9.0 mm, maximum energy of 3 J, treatment lengths of 5 to 25 mm, 100 to 240 volt power, and a console weighing 35 kg. Korean labeling also names cartridges such as Derma Shrink, A Shrink, Y Shrink, K Shrink, V Shrink, S Shrink, J Shrink and I Shrink.

To tell an Ultraformer III from an MPT, look at the modes and the cartridges. The MPT offers a Micro Pulsed mode alongside a Normal dot mode and uses ULTRA F and ULTRA BOOSTER cartridges, and Korean MPT units carry the name Shurink Universe rather than Shurink. A search of FDA's 510(k) database returns no clearance under the Ultraformer name, so note where your unit was sold.

Buyers will want the console's country of sale and labeling, both handpieces, and a list of cartridges with their depths and how much use each has had. Photograph the serial label, the main screen and each cartridge label, and include the service history and any error messages so a dealer can confirm the configuration.