CONFORMITY ASSESSMENT
Device classification
Class IIa
Rule 9
LiteCure, LLC declares that the above-mentioned product meets the fundamental requirements of the applied standards and the Medical
Device Directive 93/42/EEC+2007/47/EEC as transposed in the national laws of the Member States.
7. Specifications and Environmental Conditions
7.1.
System Specifications (LightForce XPi/XLi)
Device Family Name
Model Number(s)
Device Classifications
Medical Electrical Equipment
Laser Product
User Interface
Touch Screen Display
Emission Indicator
Mechanical Specifications
Console Dimensions
Weight
Environmental Specifications
Operating Temperature
Storage temperature
Humidity
Pressure
Cooling
Optical Specifications
Treatment Wavelengths
Skin Tone Adjustments
Maximum Output Power
Wavelength Ratio
Maximum Output Power
Wavelength Ratio
Aiming Beam Output
Aiming Beam Wavelength
Operating Modes
Pulse Frequency
Pulse Output
Laser Safety Goggles
Electrical Specifications
Input Voltage
Input Current
7.2.
Spare Parts
Warning: Do not use any accessories and/or cables not specified or sold as replacement parts. Use of unauthorized accessories
and/or optical fibers not specified or sold for use with this system may result in unsafe treatment emissions or damage to the laser
system.
Item
Beam Delivery
Assembly
Safety Goggles
Safety Goggles
Power Cord
RSR-000885-000 (6)
Route to compliance
Annex II of MDD 93/42/EEC
Council Directive
LightForce Therapy Lasers - LTS
LTS-2500-L-S8
LTS-4000-L-S8
Class I Type B device per EN/IEC 60601-1
Class 4 laser product per IEC 60825-1
10" HD Display with Touch Screen
Audible Signal (50 to 75 dB), LED (front display)
43 cm (L) x 26 cm (W) x 28 cm (H)
<30lbs
10°C to 30°C
-20°C to 70°C
≤ 80% RH Non-Condensing
70-106 kPa
Thermal Electrically Cooled with Forced Air
Light (I, II)
80% of 980 nm + 20% of 810 nm
80% of 980 nm + 20% of 810 nm
<4.0 mW
650 nm ± 20 nm
Continuous Wave (CW) or Pulsed
2, 10, 20, 100, 200, 500, 1000, 2500, 5000, 10000 Hz
50% duty cycle
OD5+ 808nm & 980nm
100-240 VAC; 50/60 Hz
≤ 400 VA
Description
Opaque protective double sheathed fiber with attached
Empower IQ™ hand piece and attachments
808 nm and 980 nm OD 5+
808 nm and 980 nm OD 5+
Medical Grade Power Cord, 2.9 m
Standards applied
IEC 60601-1:2005+A1:2012
IEC 60601-1-2:2015
IEC 60601-1-6:2010+A1:2013
IEC 60601-2-22:2007+A1:2013
IEC 60825-1:2014
LightForce
®
XPi
LightForce
®
XLi
980 nm ± 20 nm & 810 nm ± 20 nm
or
Medium (III, IV)
25W
40W
Over glasses
Regular
Dark (V, VI)
25W
100% 980 nm
32W
100% 980 nm
Image
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