Cryolipolysis Fat Freezing Machine – Official Clinical Overview & Technical Datasheet

DEVICE IDENTIFICATION

The Cryolipolysis Fat Freezing Machine (Model Series: CL-3000) is a non-invasive controlled cooling system designed for the reduction of localized subcutaneous adipose tissue via selective cryolipolysis. The device operates without laser, suction, or vacuum-assisted mechanical trauma, utilizing patented flat-plate or curved applicator technology to induce adipocyte apoptosis while preserving overlying dermal integrity.

INTERNAL HARDWARE TOPOLOGY

The system is architected around a dual-circuit thermoelectric cooling engine comprising:
– Four TEC1-12706 Peltier modules (parallel-series configurable)
– Closed-loop liquid coolant circulation with 250 mL reservoir capacity
– Brushless DC circulation pump (flow rate: 2.5 L/min)
– Dual NTC thermistor feedback sensors (accuracy: ±0.3°C)
– Isolated power supply (Input: 110-240V AC, 50/60 Hz; Output: 24V DC, 15A)
– 10.1-inch capacitive touchscreen panel with embedded treatment logic
– Silent operation: <55 dB at maximum cooling load EPIDERMAL PROTECTION MECHANISMS The device incorporates a three-layer safety cascade: 1. Real-time cutaneous temperature monitoring with automatic shutdown at +4°C deviation from setpoint. 2. Gel membrane interlayer with thermal conductivity optimized for -11°C to +5°C operating range. 3. Integrated freeze-burn prevention algorithm that modulates Peltier duty cycle when skin-modeled thermal load exceeds safety threshold. TREATMENT ADVANTAGES - Zero-downtime procedure; patients return to normal activity immediately. - No anesthesia, incisions, or compression garments required. - Clinically demonstrated 20-27% subcutaneous fat layer reduction per treated site after 60-90 days (based on caliper and ultrasound validation). - Adjustable applicator sizes to accommodate abdomen, flanks, inner/outer thighs, submental area, and bra fat. SPECIFICATION MATRIX

Parameter	Specification
Cooling Technology	Thermoelectric Peltier + Liquid circulation
Applicator Temperature Range	-11°C to +5°C (adjustable in 0.5°C increments)
Treatment Duration	35 to 60 minutes per zone (preset protocols)
Applicator Sizes	Small (2\”x3\”), Medium (4\”x5\”), Large (5\”x7\”), Curved (for thighs)
Display	10.1-inch HD capacitive touchscreen
Power Consumption	360W (max cooling); 15W (standby)
Dimensions (Main Unit)	18.5\” W x 16\” D x 20\” H (47 x 41 x 51 cm)
Weight	18 kg (39.7 lbs) including applicators

REGULATORY COMPLIANCE

The Cryolipolysis Fat Freezing Machine complies with:
– CE Medical Device Regulation (EU) 2017/745 – Class IIa
– FDA 510(k) substantial equivalence (KXXXXXX) for non-invasive fat reduction
– IEC 60601-1 (Medical Electrical Equipment Safety)
– IEC 60601-1-2 (Electromagnetic Compatibility)
– RoHS Directive 2011/65/EU
– ISO 13485:2016 certified manufacturing facility