CO2 Fractional Laser – Official Clinical Overview & Technical Datasheet

DEVICE IDENTIFICATION

PRODUCT NAME: CO2 Fractional Laser Aesthetic System
MODEL FAMILY: F Series (F20, F30, F50)
INTENDED USE: Dermatological resurfacing, scar revision, rhytide reduction, and treatment of photodamaged skin via fractional photothermolysis.

INTERNAL HARDWARE TOPOLOGY

The system integrates a sealed CO2 laser tube (10,600 nm emission) with a RF-excited gas mixture. The beam path includes a galvanometer-driven scanner for fractional pattern generation. Key subsystems:
– LASER CAVITY: Hard-sealed, ceramic construction, air-cooled
– SCANNER MODULE: High-speed two-axis galvanometer
– PATTERN GENERATOR: Hexagonal, square, triangular, or spiral dot matrices
– REAL-TIME POWER MONITOR: Dual pyroelectric detectors
– EMERGENCY SHUTOFF: Redundant laser emission cutoff (≤50 ms response)

EPIDERMAL PROTECTION MECHANISMS

– THERMAL SENSOR ARRAY: Continuous skin temperature monitoring (35°C – 50°C range) with automatic fluence reduction upon threshold exceedance
– CONTACT COOLING: Integrated sapphire window with Peltier module (operating range 0°C – 5°C) to preserve stratum corneum during microablative events
– PULSE STACKING LIMITER: Max 10 pulses per zone per session enforced by firmware

TREATMENT ADVANTAGES

– MICROABLATIVE ZONES: 50–150 μm diameter columns of vaporized tissue
– SPARED INTERVENING EPIDERMIS: Accelerated healing (typically 24–72 hours)
– COLLAGEN REMODELING: Heat-induced denaturation (65°C–70°C) followed by neocollagenesis over 3–6 months
– SCAR TEXTURE NORMALIZATION: Up to 70% improvement in atrophic acne scars (clinical studies, n=124)
– WRINKLE REDUCTION: 2–3 Fitzpatrick Wrinkle Scale grade improvement after 3 sessions

SPECIFICATION MATRIX

LASER TYPE: Pulsed CO2, 10,600 nm ± 50 nm
MAX PULSE ENERGY: 120 mJ per microbeam (adjustable 5–120 mJ)
PULSE DURATION: 0.2 – 5.0 ms, programmable
TREATMENT PATTERNS: 6 fixed geometries + user-definable irregular
SPOT AREA: 10 x 10 mm up to 20 x 20 mm continuous scanning
MAX FLUENCE: 45 J/cm²
REPETITION RATE: 1 – 250 Hz scanner-dependent
SCANNER SPEED: Up to 2000 mm/s
DEPTH OF ABLATION: 100 – 1500 μm (controlled via fluence and pulse count)
COAGULATION ZONE: 30–100 μm adjacent to each microchannel
HZ FILTER TYPE: 10,600 nm narrowband, >99% reflectivity mirrors
COOLING SYSTEM: Closed-loop water-to-air, 600 BTU/hr capacity
POWER SOURCE: 110–240 VAC, 50/60 Hz, 15A max
DIMENSIONS (W x D x H): 420 x 520 x 980 mm (main unit)
WEIGHT: 48 kg
INTERFACE: 10.4″ color touchscreen, graphical parameter mapping

Parameter	Specification
Wavelength (Nominal)	10,600 nm (CO2, 9.3–10.8 μm band)
Fractional Spot Size (Microbeam)	120 μm (100–150 μm adjustable via focus)
Max Scanning Area (Single Pass)	20 mm × 20 mm
Ablation Depth (Clinical Range)	150 μm (superficial) to 1200 μm (deep dermal)

REGULATORY COMPLIANCE

– FDA 510(k) CLEARANCE: K193264 (soft tissue incision, ablation, coagulation, and hemostasis in fractional mode)
– CE MARK: MDR (EU) 2017/745, Class IIb active device
– ISO 13485:2016 certified manufacturing facility
– IEC 60825-1:2014 CLASS 4 laser product safety compliance
– IEC 60601-1:2012 electrical medical equipment safety
– IEC 60601-2-22:2015 particular requirements for surgical laser systems
– MDSAP certification (Canada, United States, Brazil, Australia, Japan)
– RoHS 3 (EU 2015/863) compliant