Product Specifications | iHarvest — CE-Certified Laser Hair Regrowth

Key Product Claims

What sets the iHarvest helmet apart — formulation, delivery, and safety specifications.

          
212 Laser Diodes
Maximum scalp coverage for full-session stimulation across the entire treatment area.

          
650nm Wavelength
Optimal red-light penetration depth (5–10mm) reaching the hair follicle bulge region.

          
Pulsed Delivery Mode
Non-continuous pulsed waveform reduces heat buildup while maintaining therapeutic photon flux.

          
CE MDR Class IIa
Certified under EU Medical Device Regulation 2017/745 by an accredited Notified Body. Valid through May 2029.

          
Eye-Safe Design
Class IIa safety rating with auto shut-off at session end. SAR well below FCC and ICNIRP limits.

          
30-Min Sessions
Practical treatment duration — 3–5 sessions per week recommended for best results.

Full Specifications

Diode Count	212 laser diodes
Wavelength	650nm (red laser)
Delivery Mode	Pulsed (not continuous wave)
Treatment Time	30 minutes per session
Recommended Use	3-5 sessions per week
SAR	Well below FCC and ICNIRP limits
Certification	CE Mark — EU MDR 2017/745 Class IIa
Cert. Valid Through	May 2029
Manufacturer	T-Biomax Sdn. Bhd., Malaysia
Power	110-240V AC, 50/60Hz
Headset Weight	Approximately 550g
Adjustable Fit	Yes — adjustable headband
Safety Features	Auto shut-off at session end, eye-safe design
In The Box	Helmet, adapter, protective cap, documentation
Warranty	12 months manufacturer warranty

What the CE Mark Means

The CE mark indicates that iHarvest has been assessed by an accredited Notified Body and meets the essential safety and performance requirements of EU MDR 2017/745 for Class IIa medical devices.

Clinical Evidence

Low-level laser therapy (LLLT) at 650nm is supported by a growing body of clinical research for androgenetic alopecia. Key findings from peer-reviewed studies include:

Statistically significant increase in hair count vs. placebo (p < 0.05)
Improvements observed as early as week 8, with peak results at 16-24 weeks
Effective in both male and female pattern hair loss
Well-tolerated with no serious adverse events reported in trials

Buy Now — RM 3,888

How LLLT Works for Hair Regrowth

Understanding the science behind photobiomodulation

Target Tissue Depth

650nm red light penetrates to the hair follicle bulge region (5-10mm depth) where hair follicle stem cells are located. This depth is optimal for reaching the dermal papilla.

Mitochondrial Absorption

Photons are absorbed by cytochrome c oxidase (Unit IV in the mitochondrial electron transport chain), increasing electron flow and boosting ATP production by up to 150%.

Growth Factor Release

Increased ATP and cellular activity triggers the release of growth factors (FGF, VEGF, IGF-1) that stimulate follicular cell proliferation and prolong the anagen (growth) phase.

Reversal of Miniaturization

Androgenetic alopecia causes progressive follicle miniaturization. LLLT reverses this process — restoring terminal hair follicles from vellus-like miniaturized states to thicker, pigmented hairs.

Treatment Protocol

Recommended Usage

Session Duration	30 minutes per session
Frequency	3-5 sessions per week
Minimum Duration	16 weeks for visible results
Optimal Duration	24 weeks for peak results
Maintenance	2-3 sessions per week after initial period

Usage Tips

Use on clean, dry scalp for optimal light penetration
Remove any hats or hair products before treatment
Adjust the headband for a comfortable, secure fit
Do not look directly at the laser diodes
Consistency is key — results require regular use

Do not use iHarvest if you are taking photosensitizing medications, have an active scalp condition, or are pregnant. Consult your physician before use if you have any medical concerns.

iHarvest Smart Laser Helmet