Vacuum Roller Cellulite Reduction Unit – Official Clinical Overview & Technical Datasheet

DEVICE IDENTIFICATION: VACUUM ROLLER CELLULITE REDUCTION UNIT PRODUCT CODE: VR-CRU-24X / VRC-7 PRO INTENDED USE: NON-INVASIVE CELLULITE REDUCTION, LOCALIZED FAT METABOLISM ACTIVATION, AND DERMAL REMODELING VIA MECHANICAL VACUUM AND ROLLER MASSAGE. INTERNAL HARDWARE TOPOLOGY The Vacuum Roller Cellulite Reduction Unit integrates a dual-action therapeutic head combining negative pressure vacuum suction (adjustable -200 to -450 mmHg) with a bi-directional motor-driven roller array (4 to 12 RPM). The system comprises: – DIGITAL VACUUM PUMP MODULE (brushless DC, noise-optimized <65 dBA) - HIGH-TORQUE STEPPER MOTOR FOR ROLLER ASSEMBLY - TOUCHSCREEN UI WITH 7" TFT LCD, 1024x600 RESOLUTION - REDUNDANT SAFETY SHUTOFF (pressure + temperature sensors) - INTERNAL AIR FILTRATION SYSTEM (HEPA H13, serviceable every 500 hrs) EPIDERMAL PROTECTION MECHANISMS Multi-layer safety architecture includes: real-time vacuum leak detection, automatic pressure release upon skin pinching, roller stall detection, and an integrated skin temperature monitor (range 32°C–42°C). The handpiece tip is constructed of hypoallergenic ABS with a smooth, contoured edge to prevent petechiae formation. TREATMENT ADVANTAGES - Stimulates lipolysis via mechanical shear stress on adipose septae - Enhances local microcirculation (up to 300% increase per 20 min session) - Reduces edema and improves dermal density via fibroblast activation - Pain-free (<2/10 on VAS) with no required anesthetic - Zero consumables; reusable silicon roller covers (autoclavable) SPECIFICATION MATRIX

Parameter	Specification
Vacuum Pressure Range	-200 to -450 mmHg (±5%)
Roller Speed	4 to 12 RPM (bidirectional)
Roller Material	Medical grade silicone (autoclavable at 121°C)
Treatment Head Active Area	55 x 35 mm elliptical contact zone
Power Source	100–240V AC, 50/60Hz, 150W max
Dimensions (Base Unit)	380mm (W) x 420mm (D) x 910mm (H)
Weight (Main Unit)	14.5 kg
Display	7″ TFT capacitive touchscreen
Operational Noise	<65 dBA @ 1m
Safety Certifications	CE (MDR), FDA 510(k), IEC 60601 series

REGULATORY COMPLIANCE CE MDR (EU) 2017/745 – Class IIa FDA 510(k) CLEARANCE K211523 (EQUIVALENT) IEC 60601-1 (ELECTRICAL SAFETY) IEC 60601-1-2 (EMC) ROHS 3 COMPLIANT REACH SVHC COMPLIANT ISO 13485:2016 MANUFACTURING RECOMMENDED CLINICAL PROTOCOL SUMMARY TREATMENT AREA: THIGHS, BUTTOCKS, ABDOMEN, UPPER ARMS FREQUENCY: 2x WEEKLY FOR 6 WEEKS, THEN MONTHLY MAINTENANCE SESSION DURATION: 20–30 MIN PER ZONE PRESSURE SETTINGS: START -250 mmHg, INCREASE TO -400 mmHg AS TOLERATED ROLLER DIRECTION: ALTERNATING CYCLE (45 sec CW / 45 sec CCW) POST-TREATMENT: HYDRATION, AVOID NSAIDS FOR 24 HRS EXPECTED RESULTS: 1.5–3.0 cm REDUCTION IN THIGH CIRCUMFERENCE AFTER 8 SESSIONS