| Aculas®-HB-850 vs. HairMax® LaserComb® SE |
| Manufacturer |
Konftec
Corporation |
Lexington
International, LLC |
| Model
No. |
Aculas-HB-850 |
HairMax
LaserComb® SE |
| Reference
Picture |
|
 |
| Method
of Treatment |
| Handheld; |
| (1) |
Closely contact the treating
scalp |
| (2) |
Time to stop & treat (w/
HB-850B): |
| |
balding 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
 |
| Laser
Wavelength |
660nm
|
Supplier's
Specification: 655
nm
Lab. test: 650nm |
| Laser Power Output |
Aculas-HB-850A605
Lab. test: 95~102 mW/ laser
Total output power: 500 mW
Original
Specifications:
CLASS IIIa PRODUCT 
Maximum Output: 500 mW
Aculas-HB-850B655
Lab. test: 45~52
mW/ laser
Total output power: 250
mW
Original Specifications:
CLASS IIIb PRODUCT
Maximum Output: 250 mW  |
Lab.
test: 1~3 mW/
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 Beam 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 |
No |
| Alarm Indication |
LCD display
faulty channel w/ music alert; 5-channel monitor |
No |
| 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:15 minutes
per treatment
HB-850B:15
minutes
per treatment
|
What
Lexington said:
3
times per week,
10~15 minutes per treatment |
| Irradiated Laser Energy
in 15 Minutes |
HB-850A: 450 Joule
HB-850B: 225 Joule |
15.57
Joule |
Minimum
laser energy to reach biostimulation effect: 206 Joule  |
| Full Scalp Treatment Time |
HB-850A: 6.9
minutes
HB-850B: 13.8 minutes |
198.7
minutes
(3 h 18.7 m) |
| Quality Certification |
ISO 13485 |
What Lexington said:
Lexington
is an ISO 9001 & 13485 Quality
Assured laser manufacturer. We follow GMP (Good Manufacturing Practices)
of a medical device manufacturer. |
 Verification |
CE
Verification of Compliance:
EMC Directive 93/42/EEC
(Operation
Environment:
Medical Electrical Equipment)
Standard Applied: IEC 60601-1
and EC 60601-1-2 |
CE;
Non-medical Electric Equipment |
 |
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 |
