Lab. test: 1.2~2.5mW/
laser
Total output power: < 20 mWOriginal Specifications:
CLASS 3R PRODUCT
4.5 mW cw max.
Lab. test: 2.5~4.9mW/
laser
Total output power: < 40 mWComply with
FDA: 21CFR1040.10 and 21CFR1040.11
Laser Effective
Treatment Area
< 0.6
cm² (each laser spot size: 0.06 cm²)
< 0.6
cm² (each laser spot size: 0.06
cm²)
Quantity & Quality
of Lasers
9
lasers w/ 1 control loop
Laser Diode: Unknown Grade Temperature Rating: Unknown
9
lasers w/ 9 control loops
Laser Diode: Commercial Grade Temperature Rating: 40 °C
Laser
Emission Method
Direct
Irradiation 9collimated laser
beams that are neither converge nor diverge along
theirs length, resulting in very small coverage area.
Direct Irradiation 9collimated laser
beams that are neither
converge nor diverge along theirs length, resulting in very
small coverage area.
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 
