| Aculas®-HB-850 vs. HairMax® LaserComb® Premium |
| Manufacturer |
Konftec
Corporation |
Lexington
International, LLC |
| Model
No. |
Aculas-HB-850
 |
HairMax® Premium
 |
| Retail
Price + Shipping (USD) |
Aculas-HB-850A |
Aculas-HB-850B |
HairMax® Premium |
| $690 |
$990 |
$545
+ $14 = $559 |
| Total
Laser Power |
100 mW |
250 mW |
20 mW |
Price
Per Laser Power
(USD / mW) |
$6.9 |
$4 |
$28 |
| Method
of Treatment |
| Handheld; |
 |
Closely contact
the treating scalp |
 |
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 |
 |
Move to other scalp |
 |
|
Comb;
What Lexington said:
move
every 4 seconds  |
| Laser
Wavelength |
660
nm |
Supplier's
Specification: 655
nm
Lab. test: 650 nm |
| Laser Power Output |
Aculas-HB-850A
Lab. test: 18~22 mW/ laser
Total output power: 100 mW
Original Specifications:
CLASS IIIa PRODUCT 
Maximum Output: 100 mW
Aculas-HB-850B
Lab. test: 45~52
mW/ laser
Total output power: 250
mW
Original Specifications:
CLASS IIIb PRODUCT
Maximum Output: 250 mW  |
Lab.
test: 1.2~2.5 mW/
laser
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
lasers w/ 5 control loops
Laser Diode: Industrial Grade
Temperature Rating: 60 °C (140°F) 
|
9
lasers w/ 1 power switching
Laser Diode: Commercial Grade
Temperature Rating: < 40 °C
 |
Laser
Emission Method
 |
Direct Irradiation
5 independent laser
beams are EVENLY dispersed with laser scattering devices.
|
Direct Irradiation
9 collimated laser
beams that are neither
converge nor diverge along theirs length, resulting in very
small coverage area.
 |
| Laser
Biostimulation |
Positive effect for most users |
Possible for few users |
| To biostimulate the follicles,
the hair laser device must have: |
 |
moderate laser power density to
reach the follicles. |
|
sufficient emission laser beams to cover the scalp. |
|
enough delivered laser dose in
the reasonable time (15~30 minutes). |
|
| Laser
Leakage |
Very Minimum
with
reflection shield
No power 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
with comb
Loss of laser power from reflection and refraction. Generally
lasers lose 30%~50% power when reflected and refracted.
 |
| Power Supply |
Certified
Medical Grade
double
insulated
90V AC ~ 264V AC
auto switching
 |
Non-medical Grade
un-insulated
110V AC ~ 240V AC
auto switching
|
| Process Indication |
LCD (80x50 mm) dynamic
display with/ blue backlit
 |
Audible beep
tone every 4 seconds
|
| Casing |
Aluminum
case
 |
Leatherette
case
 |
| Auto Shut-off |
Yes;
with/ music alert |
No |
| Alarm Indication |
LCD
display faulty channel with/ music alert; 5-channel monitor |
No |
| Therapy
Protocol |
2~3 times per week,
HB-850A: 30 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: 90 Joule
HB-850B: 225 Joule |
31.5 Joule |
| Minimum
laser energy to reach biostimulation effect: 206 Joule |
| Full
Scalp Treatment Time |
HB-850A:
34.4 minutes
HB-850B: 13.8 minutes |
98.2
minutes
(1 h 38.2 m)
|
Dose-Time Table  |
| Quality Certification |
Good
Manufacturing Practice (GMP)- Based on ISO 13485
... Issued by Department of Health, Executive Yuan, Taiwan |
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
Mark:
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 |
