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
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
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 |
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