B2B SUPPLIER
OEM/ODM
Private Label
Customized
Wholesale
Why Choose Us?
At Siyaahi Medical, we are committed to delivering exceptional value and support to our clients in the healthcare industry.
Years
Projects
Countries
Employees
All Technologies
- Adjustable Laser Wavelength Configurations
- Compatible with Custom Applications
Custom Brand LOGO
Colors
Wavelength
Custom APP/Website
Innovative Package Design
Custom Brand LOGO
Colors
Wavelength
Custom APP/Website
Innovative Package Design
Phototherapy
Using phototherapy technology, we evaluate how light exposure enhances the absorption of active ingredients. We ensure the intensity and duration of light are carefully calibrated to optimize formula penetration, promoting a more effective skincare experience.
How it enhances skincare efficacy
Phototherapy enhances skincare efficacy by boosting collagen production, which helps firm and rejuvenate the skin. It improves the absorption of active ingredients, allowing them to work more effectively. Additionally, phototherapy reduces inflammation and redness, promoting a more even skin tone. It also supports skin healing and repair, enhances overall texture, and stimulates circulation, resulting in a healthier, radiant glow.
Hair Treatment
Siyaahi Medical is a leading provider of innovative and effective hair treatments, offering a variety of solutions tailored to meet the unique needs of every individual. Whether you’re dealing with hair loss, thinning, or scalp issues, Siyaahi Medical’s expert team uses advanced technologies and customized care to help you regain your confidence and achieve healthy, vibrant hair.
Hair Treatments at Siyaahi Medical
Hair Transplant (FUE & FUT): Advanced, minimally invasive restoration.
PRP Therapy: Stimulates hair growth using your own platelets.
Mesotherapy: Micro-injections to nourish follicles and promote regrowth.
Laser Therapy: Non-invasive light treatment for hair health.
Scalp Micropigmentation (SMP): Creates the illusion of fuller hair.
Hair Serums & Solutions: Proven products to enhance growth.
Customized Plans: Personalized solutions for your hair need
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Needling
With microneedling technology, we test how the punctures created by the needles enhance the penetration of active ingredients. We ensure the depth and frequency of needling is calibrated to maximize formula absorption, promoting a more effective skincare experience.
How it enhances skincare efficacy
Skin benefits
- Boosts collagen and elastin for firmer, smoother skin and fewer wrinkles
- Improves scars, skin texture, and minimizes enlarged pores
- Enhances skin tone, brightness, and reduces pigmentation issues
Formulation enhancements
- Helps skincare absorb deeper into the skin
- Makes active ingredients work faster and better
- Boosts results without needing stronger formulas
Our Expertise
At Siyaahi Medical, we don't just manufacture we engineer. Our team specializes in electronics, LED technology, circuit and PCB design, rapid prototyping, mass production, and global regulatory compliance, alongside select formulation expertise. We help you develop some of the best health care products on the market from concept to fully engineered, compliant devices so your brand can scale with confidence.
We also help you pull together the documentation and compliance requirements each market expects, so nothing holds up your launch.
Our Expertise Categories
Anti-aging
LED-based skincare devices engineered around the red light spectrum (630–660nm), commonly associated with collagen stimulation, fine-line reduction, and skin rejuvenation with power output calibrated for safe, at-home use.
Muscle recovery
Near-infrared devices (800–850nm) engineered for deeper tissue penetration, supporting circulation and muscle recovery, with electronics tuned to deliver stable power across extended sessions.
Anti-acne
Blue light devices designed in the 405–420nm range, engineered to target acne-causing bacteria, paired with circuit designs that balance treatment intensity with everyday safety.
Pain relief
Combination red and near-infrared devices (around 660nm and 850nm), engineered for targeted pain relief applications, with power and wavelength calibrated to each product’s intended use.
Hair growth
Low-level light therapy (LLLT) devices built around red and near-infrared wavelengths (650–680nm), engineered to stimulate hair follicles, with PCB and power systems designed for consistent, repeatable output.
Oral care
LED oral care devices engineered around the blue light spectrum (460–480nm), commonly used to accelerate whitening treatments, alongside select formulation-based oral care products.
Regulatory & Compliance Support
Bringing a healthcare product to market means meeting different requirements in every country you sell in. Our team helps you plan for this from day one, so your device is designed, tested, and documented to meet the right standards not retrofitted later.
United States — FDA
Most LED and light therapy devices making medical or therapeutic claims are regulated as Class II medical devices, requiring FDA 510(k) premarket clearance. Typical requirements include compliance with:
- IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home use)
- IEC 60601-2-83 (light therapy equipment)
- IEC 62471 (photobiological safety)
- ISO 10993 (biocompatibility), IEC 62304 (software), IEC 62366-1 (usability)
- IEC 62133-2 (battery safety) for rechargeable/wireless devices
Submissions must demonstrate substantial equivalence to a predicate device and include detailed spectral/irradiance data and performance testing under FDA special controls.
European Union — MDR, CE Marking
Devices sold in the EU require CE marking under the Medical Device Regulation (MDR 2017/745). Higher-risk devices (often Class IIa and above for light therapy) require:
- Review by a Notified Body (e.g., BSI, TÜV SÜD, DEKRA)
- A certified ISO 13485 quality management system
- RoHS compliance for electronic components
- Full technical documentation, clinical evaluation, EU Declaration of Conformity, and PMS/PMCF plans
- Registration in EUDAMED and compliance with MDR labeling/UDI
Australia — TGA
Devices must be included in the Australian Register of Therapeutic Goods (ARTG) before sale. The TGA often recognizes existing CE marking (MDR), FDA 510(k)/PMA, or MDSAP certification as part of conformity assessment, but an Australian Sponsor is mandatory and must submit:
- Essential Principles checklist
- Clinical evaluation
- Australian-specific labeling and sponsor
Canada — Health Canada
A Medical Device Licence (MDL) is required for Class II–IV devices. Health Canada mandates:
- MDSAP certification (ISO 13485 alone is not sufficient), with Canada in scope
- Bilingual English/French labeling and IFU
- Summary of safety and effectiveness, risk management (ISO 14971), and post-market data under updated 2026
India — CDSCO
Import and sale require a CDSCO import license (Form MD-14 application, Form MD-15 license) filed through the SUGAM portal by a locally appointed Indian Authorized Agent (IAA). Typical documentation includes:
- Notarized Power of Attorney for the IAA
- Device Master File, Plant Master File
- Foreign manufacturer’s ISO 13485 certificate
- Free Sale Certificate from country of origin
Label artwork, IFU, and clinical/literature support as needed many electronic components or finished devices may also require separate BIS registration under India’s Compulsory Registration Scheme, depending on product classification.
How We Help We help you plan the right regulatory pathway early, coordinate with accredited testing labs and certification bodies, prepare technical documentation, and align your device’s engineering, materials, and labeling with each target market’s requirements so you’re never navigating compliance alone.
Our Process
Our Process
01 . Feasibility Analysis
We evaluate your product concept for market viability, target-market regulatory pathway (FDA, MDR, TGA, Health Canada, CDSCO), and manufacturing feasibility including electronics and LED component sourcing before development begins.
02 . Product Design
Our team translates your vision into detailed specifications, covering device housing, electronics layout, and, where applicable, formulations all tailored to your brand.
03 . Engineering
We design and validate circuits and PCBs, select the right LEDs, and calibrate wavelength and power output to match your product’s intended treatment application and target-market safety standards, such as IEC 60601-1 and IEC 62471.
04 . Fast Prototyping
Rapid prototyping produces working devices fully functional PCBs, LED assemblies, and enclosures so you can test, review, and approve before committing to full-scale production.
05 . Large Scale Production
Once approved, our certified manufacturing partners scale electronics assembly and device production under ISO 13485 aligned quality processes, delivering consistent, compliant products, ready for market.
Feasibility Analysis
Our experts begin by assessing the practicality of your idea. In this phase, we focus on objectively identifying the strengths and weaknesses of your concept.
This approach helps us determine the most effective way to move forward with the project.
Product Design
Product design involves the process of conceptualizing and creating a functional, aesthetically pleasing, and user-friendly product. It combines creativity, functionality, and technical knowledge to bring your ideas to life, ensuring that the product meets both user needs and market demands.
Engineering
Our in-house convert the design requirements into technical specifications, ensuring that the product is not only visually appealing but also practical in terms of manufacturing and product planning.
Fast Prototyping
Rapid prototyping is crucial for projects with tight timelines. This phase enables the tangible visualization of the concept, allowing you to see, touch, and test it with your users.
Large Scale Production
We organize and prioritize production with pre-pilot quantities in our facilities. This phase helps us identify the necessary adjustments to optimize production timelines, while ensuring consistent product quality and performance from start to finish.
Built for Brands That Demand Excellence
Siyaahi Medical partners with brands, distributors, startups, and retailers who expect more than a standard manufacturing relationship. We combine electronics and device engineering expertise, quality-certified production partners, and end-to-end support to help you launch and scale healthcare products and devices with confidence. Whether you're building your first line or expanding an established portfolio, we deliver the reliability and flexibility ambitious brands demand.
What We Do
From concept to shelf, we manage every step of product development circuit and PCB design, LED selection, wavelength and power calibration, rapid prototyping, and mass production with formulation support available for select product lines.
We also guide you through country-specific regulatory pathways, including FDA 510(k), EU MDR/CE marking, TGA/ARTG, Health Canada MDL, and CDSCO import licensing, so your device is designed to meet the right standards from day one. We also help medical equipment & supply wholesalers and medical equipment wholesalers expand into private-label healthcare devices and wellness lines, adding new revenue streams without new infrastructure. Our engineering capabilities and global sourcing network ensure your products stay competitive, compliant, and ready to scale as your business grows.
Frequently Asked Questions
Have a question that's not covered here? Our team is ready to discuss your requirements, provide expert guidance, and help you find the right solution for your project.
No. We handle electronics, PCB design, and manufacturing through a certified partner network, so you can launch the best health care products under your brand without any investment in infrastructure.
We specialize in anti-aging, anti-acne, hair growth, muscle recovery, pain relief, and oral care primarily through LED and light-therapy devices, alongside select formulated products.
Yes. We partner with medical equipment & supply wholesalers, distributors, and retailers looking to expand into private-label healthcare devices and wellness products.
Wavelength and power selection depend on the treatment application for example, red light around 630–660nm for skin rejuvenation, blue light around 405–420nm for acne treatment, or near-infrared around 800–850nm for deeper tissue applications. Our engineering team calibrates each device’s LEDs and power output to match its intended use.
Yes. We support market entry into the US (FDA), EU (MDR/CE, BSI), Australia (TGA/ARTG), Canada (Health Canada/MDSAP), and India (CDSCO import licensing, BIS), helping you plan the right pathway, documentation, and testing for each market.
Timelines vary by product complexity and target-market regulatory pathway, but our process from feasibility analysis and PCB design to fast prototyping is designed to get you to market as efficiently as possible.
Yes. Beyond engineering and production, we support branding, packaging design, technology integration, and global sourcing, so you can build a complete, market-ready healthcare brand.
Fast and Accurate Results
Certified Equipment
Experienced Professionals
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Let's Build Your Light Therapy Product Together
Whether you’re planning a new light therapy device, exploring OEM/ODM customization, or preparing for global market requirements, Siyaahi Medical is here to guide you every step of the way.