| Aculas®-HB-850 vs. HairMax® LaserComb® Premium |
| Manufacturer |
Konftec
Corporation |
Lexington
International, LLC |
| Model
No. |
Aculas-HB-850 |
HairMax® Premium |
| Picture |
 |
 |
| Price |
| Retail
Price + Shipping (USD) |
Aculas-HB-850A |
Aculas-HB-850B |
HairMax® Premium |
| $690 |
$990 |
$495
+ $13 = $508 |
| Total
Laser Power |
100 mW |
250 mW |
20 mW |
Price
Per Laser Power
(USD / mW) |
$6.9 |
$4 |
$25.4 |
| Laser
Part |
| Laser
Wavelength |
660nm |
Supplier's
Specification: 655
nm
Lab. Test: 650nm |
| Laser Power Output |
Aculas-HB-850A |
Aculas-HB-850B |
HairMax® Premium |
| Lab. Test |
18~22 mW/ laser |
45~52 mW/ laser |
1.2~2.5 mW/ laser |
| Total Power |
100 mW |
250 mW |
< 20 mW |
| Original Specifications |
CLASS IIIa PRODUCT 
Maximum Output:100 mW
|
CLASS IIIb PRODUCT
Maximum Output:250 mW
 |
CLASS 3R PRODUCT
4.5 mW cw max
 |
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
 |
| Delivered
w/ Laser Power Test Report |
 |
 |
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.
 |
| Operation |
| 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 Effective
Treatment Area |
22 cm²
 |
< 0.6
cm²
(each Laser Beam Spot Size: 0.06
cm²)
 |
| Process
Indication |
LCD
(80x50 mm) dynamic display with/ blue backlit
 |
Audible beep tone
every 4 seconds
|
| Auto
Shut-off |
with
music alert |
 |
| Alarm
Indication |
LCD
display faulty channel with/ music alert; 5-channel monitor |
 |
| Effectiveness |
| 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). |
|
| 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 (3 Joule/cm2) |
| 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 < |
| 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.
 |
| Verification |
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). |
| Home Therapy Applications |
Multiple home treatments for:>
Hair
Loss
Acne
Wrinkle
Wound,
Burn, Operation Wound
Skin
Diseases
Pain
Relief |
Hair
Loss Treatment Only |