Aculas®-HB-850 vs. HairMax® LaserComb® SE |
Manufacturer |
Konftec
Corporation |
Lexington
International, LLC |
Model
No. |
|
HairMax
LaserComb® SE |
Method
of Treatment |
Handheld;
(1) Closely contact the treating scalp
(2) Time to stop & treat (w/
HB-850B):
*bald area - stop for 4.4 minutes
*thinning area - stop for 2.2 minutes
*normal area - stop for 42 seconds
(3) Move to other scalp |
Comb;
What Lexington said:
move
every 4 seconds |
Casing |
|
Plastic
case
 |
| Laser
Wavelength |
660
nm
|
Supplier's
Specification: 655
nm
Lab. test: 650 nm
|
| Laser Power Output |
Aculas-HB-850A
Lab. test: 18~22mW/ laser
Total output power: 100 mW
Original
Specifications:
CLASS IIIa PRODUCT 
Maximum Output: 100 mW
Aculas-HB-850B
Lab. test: 45~52mW/
laser
Total output power: 250
mW
Original Specifications:
CLASS IIIb PRODUCT
Maximum Output: 250 mW  |
Lab. test: 1~3mW/
beam
Total output power: < 20 mW
Original Specifications:
CLASS 3R PRODUCT
4.5 mW cw max.
|
| Delivered
w/ Laser Power Test Report |
 |
 |
| Laser Effective Treatment
Area |
22 cm² |
< 0.6
cm²
(each laser spot size: 0.06
cm²) |
Quantity
&
Quality
of Lasers |
5
independent lasers
Industrial Grade;
Temperature Rating: 60 °C (140°F) |
1
actual laser
Industrial Grade: Unknown
Temperature Rating: Unknown |
Laser
Emission Method
 |
Direct Irradiation
5 independent laser
beams are EVENLY dispersed with laser scattering devices.
No power loss
Laser Dispersion Simulation
Cover More Scalp
 |
Mirror Reflection
1 clipped and collimated laser
beam measuring 24~26mW at the aperture is reflected by a saw tooth-shaped
reflector (plastic mirrors) into 5 individual beams, produces
a parallel beam that neither
converges nor diverges along its length, resulting in uneven
coverage.
30%~ 50% power
loss due to reflection
 |
| Laser
Leakage |
Very Minimum
w/
reflection shield
No loss with direct laser diodes. No mirrors, no lens. Advanced
laser scattering devices evenly disperse 5 laser beams.
Please note the
handheld unit must be held to closely contact the scalp. |
Big Quantity
less
efficacy
Loss of power through plastic mirror refraction and perspex
cover, proven uneven dispersion. Generally, lasers lose 30%~50%
power when reflected.
|
| Power Supply |
Certified
Medical Grade
double
insulated.
90V AC ~ 264V AC
auto switching
|
Non-medical Grade
un-insulated.
110V AC ~ 240V AC
auto switch
|
| Process Indication |
LCD (80x50 mm) dynamic display
w/ blue backlit |
Audible beep
tone every 4 seconds |
| Auto Shut-off |
Yes; w/ music
alert |
|
| Alarm Indication |
LCD display
faulty channel w/ music alert; 5-channel monitor |
|
| Weight |
250 g (Handheld unit) |
< 400 g
includes a metal
weight in the handle to make more 'solid' feel
|
| Therapy Protocol |
2~3 times per week,
HB-850A:30 minutes
per treatment
HB-850B:15
minutes
per treatment
|
|
| Irradiated Laser Energy
in 15 Minutes |
HB-850A: 90 Joule
HB-850B: 225 Joule
|
15.57
Joule |
Minimum
laser energy to reach biostimulation effect: 206 Joule  |
| Full Scalp Treatment Time |
HB-850A: 34.4 minutes
HB-850B: 13.8 minutes
|
198.7
minutes
(3 h 18.7 m)
|
| Dose-Time Table |
| Quality Certification |
|
|
 Verification |
|
|
|
Applying |
Yes, K060305
Classification Name:
Infrared
lamp per CFR 890.5500
What FDA
said:
...the device is substantially equivalent
to legally marketed predicate devices
... do not require approval of a premarket approval application
(PMA). |
| Applications |
Multiple home treatments for:
 Hair
Loss
Acne
Wrinkle
Wound,
Burn, Operation Wound
Skin
Diseases |
Hair
Loss Treatment Only |
