ISO 13485 Certified Medical Aesthetic OEM/ODM

Microneedling Manufacturer & Supplier: Precision Transdermal Engineering

Pioneering Next-Generation Automated Microneedle Pens, RF Fractional Systems & Bio-Actuated Cartridge Architectures for Global Aesthetic Brands, Dermatology Chains & MedSpas Since 2013.

Direct-From-Factory Core Portfolio

Clinical-Grade Microneedling & Phototherapy Platforms

Engineered for high biological absorption, uniform penetration depth, and low-friction oscillation. Fully customizable for OEM private label and bespoke ODM medical hardware.

SKU: BIO-Q2 Biopen Q2 Professional Automated Microneedling Derma Pen

Biopen Q2 Wireless Derma Pen

High-torque brushless coreless motor with 6-speed calibrated needle oscillation and fluid anti-backflow cartridge integration.

0-2.5mm Gauge 18,000 RPM Anti-Backflow
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SKU: DP-PRO Professional Medical Grade Microneedling Device

Professional Clinical Derma Pen

Aviation-grade aluminum unibody with magnetic cartridge dock, precision depth vernier scale, and dual rechargeable battery modules.

Class II Medical Surgical Steel Type-C Fast Charge
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SKU: LM15 Anti-Aging 4 Colors Light Therapy Ice Function Skin Care Silicone Mask LM15

Anti-Aging 4-Color Cooling Mask (LM15)

Flexible food-grade silicone LED mask integrated with cryo-soothing thermoregulation for accelerated post-microneedling recovery.

415-830nm Ice Compress TUV Food-Grade
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SKU: LM10 Beauty Colorful PDT Light Therapy Machine LED Facial Mask LM10

PDT Facial Photo-Therapy Mask (LM10)

High-density multi-spectral photodynamic therapy unit engineered for clinical aesthetic salons targeting collagen induction and blemish care.

Multi-Spectral Ergonomic Rigid CE & RoHS
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SKU: LH02 Hair Growth & Regrowth Laser Cap Helmet for Hair Loss LH02

Laser Scalp Regeneration Helmet (LH02)

Cold diode 650nm LLLT architecture designed to synergize with scalp microneedling protocols for cellular follicular revitalization.

650nm Laser Diode Full Scalp Matrix Auto-Timer
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SKU: LM06 Flexibility Red Light Therapy Device Facial PDT Machine LM06

Contour PDT Red Light Therapy (LM06)

Flexible dual-wavelength 630nm + 830nm near-infrared array delivering uniform photobiomodulation to cervical and facial tissue contours.

630nm / 830nm NIR Medical Silicone High Irradiance
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SKU: MS-12 Silicone LED Light Therapy Facial Mask

Silicone Bio-Matrix Phototherapy Unit

Ultralight silicone skin mask engineered for post-procedure dermal calming, optimized for clinic takeaway retail programs.

Deep Penetration Soft-Touch Silicon Rechargeable
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SKU: LH-90 Clinical Laser Hair Restoration Device

Photonic Scalp Treatment System

Multi-diode low-level laser system combining clinical follicle activation with ergonomic comfort, certified CE and RoHS compliant.

Medical Diodes Integrated Sensor Custom Mold
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Industry White Paper & Technical Audit

Architecting the Next Era of Automated Transdermal Drug Delivery & Collagen Induction

The contemporary aesthetic medicine and clinical dermatology landscapes demand exceptional repeatability, verified biological safety, and uncompromised precision. Microneedling—historically rooted in manual epidermal puncture rollers—has evolved into a sophisticated discipline of mechatronic transdermal engineering.

Shenzhen Fanrun Technology Co., Ltd. (Established 2013) operates at the vanguard of this paradigm shift. By integrating micro-electromechanical systems (MEMS), sub-micron medical needle sharpening, and advanced cleanroom sterilization, we empower global brands to transition from generic beauty gadgets to certified therapeutic instruments.

Our OEM/ODM solutions solve the core mechanical pain points that plague commodity derma pens: needle bending under shear stress, fluid backflow contamination, RPM attenuation under tissue resistance, and dermal micro-tearing caused by non-perpendicular vertical stroke deflection.

Download Engineering White Paper
Classification of Microneedle Technologies and Devices Laboratory Analysis
2013+

Founding Year

360+

Global Validated Patents

200Km²

Industrial Footprint

<0.02mm

Needle Stroke Tolerance

R&D Trajectory

Microneedling Technology Roadmap: From Mechanical Puncture to Bio-Actuation

A comprehensive technical categorization of transdermal microneedle platforms, structural physics, and the impending transition toward smart delivery matrices.

1. Solid Microneedles

Engineered via surgical stainless steel (SUS304/SUS316L) or titanium alloy. Focuses purely on microscopic stratum corneum perforation to induce natural collagen synthesis (CIT) and pre-treat the dermis prior to topical serum application.

  • Bevel grind angles under 15°
  • Zero chemical reactivity
  • Minimal epidermal drag coefficient

2. Coated Micro-Arrays

Solid needle substrates layered with dried pharmacological or peptide compounds. Upon tissue insertion, the ambient biological moisture in interstitial fluid dissolves the functional outer coating for rapid direct delivery.

  • Immediate compound bioavailability
  • Precision surface energy adhesion
  • Ideal for concentrated actives

3. Dissolving Biodegradable

Fabricated from crystalline crosslinked hyaluronic acid (HA), poly(lactic-co-glycolic acid) (PLGA), or chondroitin sulfate. Needles fully dissolve inside interstitial fluid, releasing encapsulated high-molecular macromolecules without bio-hazardous sharps waste.

  • No sharp biohazard residual
  • Sustained release profiles
  • Zero mechanical needle retrieval

4. Hollow & RF Integrated

Features internal micro-lumens for continuous controlled pneumatic infusion of biologics, PRP, or exosomes, or incorporates bipolar Radiofrequency (RF) thermal energy delivery directly into deep reticular fibroblasts without surface epidermal burns.

  • Volumetric dosage precision
  • Deep reticular fractional heating
  • Smart impedance bio-sensing
Architecture Type Needle Substrate Penetration Depth Primary Clinical Target Manufacturing Complexity
Motorized Auto-Derma Pen Medical SUS304 / SUS316L 0.25 mm – 2.50 mm (Adjustable) Atrophic Scars, Alopecia, Collagen Remodeling High Precision MEMS
Fractional RF Microneedling Gold-Insulated Titanium Needles 0.50 mm – 4.00 mm (Stepper Motor) Skin Laxity, Deep Rhytids, Dermal Coagulation Advanced RF Circuitry
Hydra-Dosing Infusion Pen Passivated Surgical Stainless Steel 0.20 mm – 1.50 mm (Continuous) Transdermal Exosome & PDRN Mesotherapy Micro-Fluidic Chamber
Dissolvable HA Micro-Patch Crosslinked Sodium Hyaluronate 150 μm – 450 μm (Epidermal) Targeted Peri-Orbital Fine Lines, Melasma GMP Class 7 Cleanroom
Macro Industry Ecosystem

Macro Industry Solutions: Tailored Engineering for Every Market Sector

A structured approach to device design, torque calibration, and sanitary packaging tailored to varying jurisdictional operator standards and commercial distribution vectors.

Clinical Dermatology & Plastic Surgery

Medical-grade automated pens capable of deep dermal remodeling up to 2.5mm. Designed with ultra-rigid needle guides to completely eliminate deflection shear, reducing patient discomfort and recovery downtime.

  • High-torque motor (no stalling in scar tissue)
  • EO gas sterilized single-use cartridges
  • Fully autoclavable pen sleeves
  • FDA 510(k) and Medical CE device documentation

Medical Spas & Aesthetic Chains

Optimized for rapid treatment turnarounds and multi-practitioner consistency. Intuitive digital touch interfaces, hot-swappable lithium-ion batteries, and foolproof click-lock cartridge mechanisms.

  • Dual-battery continuous operational cycles
  • Custom brand livery and pantone matching
  • Sterility validation certificates with each batch
  • Low vibration damping for operator comfort

At-Home Consumer Beauty Brands

Class-compliant consumer micro-exfoliation pens limited to safe epidermal depths (≤0.25mm or nano-silicon tips). Designed with consumer-facing fail-safe mechanics, premium magnetic packaging, and app connectivity.

  • Non-invasive nano-chip & micro-depth lock
  • Intelligent pressure-sensing safety cutoff
  • Custom retail packaging and unboxing kits
  • Global electrical compliance (CE, FCC, RoHS, UKCA)
Shenzhen Smart Manufacturing

China Factory 4.0: Supply Chain Resilience & Lean Efficiency Advantages

Situated in Shenzhen—the epicentre of global hardware innovation—Fanrun integrates industrial design, CNC micro-machining, precision injection tooling, and medical-grade cleanroom assembly into one sovereign, fully traceable production continuum.

Unlike assembly-only intermediaries, we manufacture our sub-assemblies in-house. Our facility houses 5-axis CNC machining centers for aircraft aluminum chassis, high-speed automated needle grinding cells, and Class 100,000 cleanrooms for sterile blister packaging.

This vertical depth insulates our global partners against international supply disruptions, guarantees stable BOM costs, and cuts prototype-to-mass-production iteration cycles down to weeks instead of quarters.

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Automated Vision QC

Every single needle tip is inspected via high-magnification automated optical inspection (AOI) to eliminate microscopic hooks, burrs, or geometric variations before cartridge assembly.

Micro-Motor Dynamometer Testing

Brushless drive assemblies undergo 1,000-hour stress and thermal dynamometer cycling to guarantee smooth torque delivery and noise dampening under 45 dB.

Traceable Lot Serialization

Full digital MES lot traceability across incoming raw stainless steel, motor assemblies, medical silicones, and Ethylene Oxide (EO) sterilization lot indices.

Risk Mitigation & Regulatory Assurance

Regulatory Compliance: Navigating MDR, FDA 510(k), CE & Biocompatibility

Importing medical aesthetic hardware requires stringent proof of safety. Fanrun provides complete technical files, biocompatibility dossiers, and certified test reports to ensure flawless customs entry and retail compliance.

ISO 10993 Biocompatibility

All skin-contact materials, surgical stainless needles, and medical silicone elastomer components have undergone rigorous TUV and SGS testing for cytotoxicity, intracutaneous irritation, and delayed-type hypersensitivity.

FDA 21 CFR 878.4820 Compliance

We provide full technical documentation supporting 510(k) pathway readiness for automated microneedle devices, addressing essential safety controls including anti-backflow fluid isolation membranes and needle puncture consistency.

EU MDR (2017/745) Class IIa Readiness

Detailed technical construction files (TCF), electrical safety testing (IEC 60601-1 / EN 60601-1-2), risk management protocols (ISO 14971), and CE/RoHS directives for accelerated notified body evaluation across the European Union.

CE Compliance Certification Fanrun CE Medical Directive
RoHS Environmental Safety Certificate RoHS 2.0 Directive
TUV Material Safety Testing TUV Biocompatibility
SGS Food Grade Silicone Report SGS Food Grade
Quality Management ISO 13485 ISO 13485 / Patents
Sourcing Director's Checklist

Global Enterprise Sourcing Criteria: Evaluating Microneedling Factories

What procurement directors, brand founders, and chief medical officers should scrutinize before locking in multi-year device supply agreements.

Fluid Isolation Architecture

Does the needle cartridge incorporate a cross-contamination silicone membrane preventing serum backflow into the reciprocating motor piston? Without this, cross-infection is a massive liability.

Needle Penetration Perpendicularity

Does the drive shaft wobble at high oscillation velocities? Angular deflection greater than 3° will cause dermal tearing and micro-scratches rather than clean cylindrical micropores.

Battery Cell Safety Certifications

Are internal lithium-ion power packs certified under UN38.3, MSDS, and IEC 62133? Global air cargo customs will confiscate non-compliant battery shipments immediately.

Sterile Packaging Integrity

Are needle cartridges blister packed using medical-grade Tyvek/dialysis paper with biological chemical indicators proving authentic Ethylene Oxide (EO) sterilization?

Trusted By Global Industry Leaders
Direct Answers

Frequently Asked Questions: Technical, Commercial & Regulatory

Everything procurement heads and private label brand managers need to know before initiating samples or issuing a purchase order.

Does Fanrun provide complete OEM private label and ground-up ODM tooling?

Yes. OEM private label includes laser engraving your logo, custom anodized body finishes, Pantone matched housings, bespoke printed retail packaging, and customized instruction manuals. For ODM clients, we execute complete industrial design, 3D CAD modeling, PCB firmware programming, injection mold tooling, and dedicated cartridge lock architectures.

What needle gauge and configuration options are supported in your cartridges?

Our standard cartridge portfolio spans 9-pin, 12-pin, 16-pin, 24-pin, 36-pin, 42-pin, and nano-silicon round/square wafer arrays. Needles are fabricated using medical grade 304 or 316L surgical stainless steel, electropolished to an ultra-sharp 33-gauge to 30-gauge tip diameter (0.18mm - 0.25mm) for minimal client trauma.

How does your factory prevent cross-contamination in automated microneedling pens?

Our cartridges are engineered with a proprietary medical-grade silicone diaphragm barrier. This elastomeric seal completely isolates the fluid channel and needle carrier from the motorized reciprocating drive shaft, ensuring that blood, serum, or exosome formulations cannot backflow into the internal mechanics of the handpiece.

What international quality certifications do your devices and materials possess?

Our products carry verified CE (EMC/LVD), RoHS, FCC, and UKCA certifications. Internal batteries hold full UN38.3 and MSDS transport documentation. All skin-contact silicone and steel components have successfully passed TUV and SGS testing for food-grade safety and ISO 10993 biocompatibility compliance.

What is your Minimum Order Quantity (MOQ) and production turnaround time?

Standard model sampling requires 3-5 working days. Private label laser-logo OEM starts at a modest 200–500 units per order depending on housing complexity. Full custom ODM injection projects require approximately 25-35 days for mold tooling followed by 20 days for mass batch production.

How can our compliance team authenticate your test reports before issuing a PO?

We believe in absolute transparency. Upon request, our sales engineering staff will provide formal test report serial numbers and digital certificates. You can directly verify these certificate numbers via the official online verification portals of issuing laboratories such as TUV Rheinland and SGS.

Full Product Matrix

Enterprise Sourcing: Ready-to-Brand Clinical Hardware

Select any baseline platform below to request custom bill-of-materials, factory pricing tiers, and OEM sample prototypes.

SKU: LM15-PRO Anti-Aging 4 Colors Light Therapy Ice Function Silicone Mask

4-Color Cryo Silicone Mask (LM15)

Integrated cooling thermal plates with 415nm-830nm LED phototherapy for post-derma pen irritation abatement.

Dual Action Food Silicone SGS Tested
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SKU: LM10-CLINIC Beauty Colorful PDT Light Therapy Machine LED Facial Mask

Multi-Spectrum PDT Mask (LM10)

Ergonomic salon-grade hard mask delivering uniform optical flux for acne clearance, tone brightening, and collagen activation.

High Flux Density CE Certified Multi-Select
Configure PDT Station
SKU: LH02-CAP Hair Growth Laser Cap Helmet LH02

Laser Hair Regrowth Helmet (LH02)

Scalp stimulation cap utilizing 650nm monochromatic low-level laser diodes to boost ATP production in dormant follicles.

650nm Laser Full Scalp Matrix Automatic Timer
Configure Laser Helmet
SKU: LM06-FLEX Flexibility Red Light Therapy Device LM06

Contoured Red/NIR Panel (LM06)

Flexible medical silicone chassis that wraps perfectly around the face, neck, or décolleté for optimal energy absorption.

630nm / 830nm Ultra Flexible Easy Clean
Configure Flexible LED
SKU: MP-PRO Biopen Q2 Microneedling Derma Pen Device

Biopen Q2 Mechatronic Derma Pen

Ergonomic knurled grip, digital RPM display, and micrometer-precision depth collar delivering dependable clinical punctures.

High Precision Digital Display OEM Housing
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SKU: MED-DERM Clinical Microneedling Hardware

Clinical Micro-Needle Infusion Station

Dual wired and wireless operation with high-torque brushless drive mechanism, designed for dermatology clinic protocols.

Dual Power Aviation Metal Low Decibel
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SKU: LED-FLEX LED Light Therapy Mask Platform Range

Silicone Photodynamic Beauty Mask

Ultra-flexible wearable mask providing full dermal phototherapy with targeted wavelength arrays and wireless remote control.

Wireless Control Skin Contact Grade TUV Verified
Inquire Mask Platform
SKU: CAP-ULTRA Flexible Red Light Therapy Device for Face and Scalp

Scalp & Facial Photobiomodulation Pad

Multi-purpose flexible red light emitter matrix contoured for combined cranial hair stimulation and cervical skin rejuvenation.

Dual Area Application High Irradiance RoHS Directives
Inquire Scalp Device
Ready to Manufacture

Partner With China's Leading Microneedling OEM/ODM Factory

Elevate your brand margin with high-precision engineering, ISO 13485 cleanroom manufacturing, and comprehensive global compliance documentation direct from Shenzhen.

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