DOLORCLAST Focused Shock Waves

The DOLORCLAST Focused Shock Waves system delivers acoustic pressure shockwaves using piezoelectric technology to treat chronic, full-thickness diabetic foot ulcers in adults aged 22 and older. The device is used in conjunction with standard diabetic ulcer care and is limited to ulcers ≤16 cm² that extend through skin layers but without bone exposure, and only for ulcers lasting more than 30 days.

The DOLORCLAST uses piezoelectric shock wave generation (vs. electromagnetic in the predicate), has a larger 99 mm applicator head diameter (vs. 62 mm), and achieves slightly different penetration depths and focal zones across three gel pad offsets. Both systems operate continuously at 1–8 Hz with operator-selectable intensity, frequency, and pulse count; both use similar console interfaces and electrical protections (Class I, B).

IEC 61846 and IEC 63045 for acoustic pulse characterization; IEC 62304 Edition 1.1 for software life-cycle processes; IEC 60601-1:2005 + A1:2012 and IEC 60601-1-2:2014 for electrical safety and EMC; ISO 10993-1, -10, -11, and -23 for biocompatibility testing of patient-contacting materials.

Both devices share identical indications, product code (PZL), regulatory class (II), continuous operating mode, operator parameter control, and clinical mechanism (extracorporeally induced pressure pulses for diabetic foot ulcer treatment). Acoustic pulse characterization testing demonstrated comparable pressure field output, and lifetime/functional testing confirmed the DOLORCLAST meets equivalent performance specifications. Although the DOLORCLAST uses piezoelectric rather than electromagnetic generation and has different applicator geometry, the similar depth ranges and comparable focal zones support equivalent clinical performance for the same indication.