Qty of Laser: 9
Lab. test: 1.2~2.5mW/
laser
Total output power: < 20 mWOriginal Specifications:
CLASS 3R PRODUCT
4.5 mW cw max.
Qty of Laser: 9
Lab. test: 2.5~4.9mW/
laser
Total output power: < 40 mW
Comply with
FDA:
21CFR1040.10 and 21CFR1040.11
Quantity & Grade
of Lasers
9
lasers w/ 1 control loop
Laser Diode: Unknown Grade Temperature Rating: Unknown
9
lasers w/ 9 independent control loops
Laser Diode: Commercial Grade Temperature Rating: 40 °C
Laser
Emission Method
Direct
Irradiation 9 collimated laser
beams that are neither converge nor diverge along
theirs length, resulting in very small coverage area.
Direct Irradiation 9 collimated laser
beams that are neither
converge nor diverge along theirs length, resulting in very
small coverage area.
Effectiveness
Method
of Treatment
Comb;
What manufacturer said: move every 4 seconds
Direct
Irradiation;
Bind all laser pointers together and irradiate the scalp.
Laser Effective Treatment
Area
< 0.6 cm² (each Laser Beam Spot Size: 0.06 cm²)
< 0.6 cm² (each Laser Beam Spot Size: 0.06 cm²)
Safety
& Verification
Laser
Leakage
Big Quantity
w/ comb Loss of laser
power from reflection and refraction. Generally, lasers lose 30%~50%
power when reflected and refracted.
Depend on
holding position
Loss of laser power from reflection and refraction. Generally, lasers
lose 30%~50% power when reflected and refracted.
Power Supply
Non-medical
Gradeun-insulated.
110V AC ~ 240V AC
auto switching
Batteries
or
Yes, K060305 Classification Name:Infrared lamp per CFR 890.5500What FDA said: ...the device is substantially equivalent to
legally marketed predicate devices ... do not require
approval of a premarket approval application (PMA).
or 
