Custom-branded aesthetic laser equipment manufactured in our FDA 510(k) cleared, ISO 13485 certified facility. From a single logo change to a fully custom device — we build your brand on proven, certified hardware.
Original Equipment Manufacturing
Best for: Distributors who want a branded product quickly with existing certifications
Original Design Manufacturing
Best for: Established brands wanting a unique, differentiated product line
Share your brand vision, target market, budget, and customization requirements. We'll recommend the best product base and OEM/ODM approach.
1–3 daysReceive a branded sample unit (for OEM) or design mockups (for ODM). Review logo placement, UI design, packaging, and hardware specs.
1–3 days (OEM) / 7–10 days (ODM)Finalize specifications, pricing, MOQ, and delivery timeline. Sign OEM/ODM agreement with IP protection and confidentiality clauses.
1–2 daysYour branded devices are manufactured in our ISO 13485 certified facility. Real-time production updates with photos and videos.
3–5 daysEvery unit undergoes full QC testing: electrical safety, laser output calibration, cooling system, UI functionality. Video inspection available before shipment.
2–3 daysProfessional export packaging. Air/sea freight arranged. 2-year warranty. Remote technical support + training. Spare parts stocked for your region.
3–7 days shipping| Element | OEM | ODM | Description | |
|---|---|---|---|---|
| Logo & Branding | Yes | Yes | Your logo on machine body, screen boot animation, handpiece, packaging, user manual | |
| Machine Color | Yes | Yes | Custom body color, accent color, handpiece color — Pantone matched | |
| UI Language & Software | Yes | Yes | Any language for screen UI. Custom treatment protocols, preset parameters, clinic workflow | |
| Packaging Design | Yes | Yes | Custom-branded flight case, retail box, user manual, quick-start guide design | |
| Handpiece Design | Limited | Handpiece shell color and logo — yes. Internal optical/electrical design — no (affects certification) | ||
| Hardware Specifications | OEM: No | ODM: Yes | ODM allows modifying power, spot size, wavelength configuration, applicator type, cooling system | |
| Certification | Uses ours | New if needed | OEM uses existing FDA/CE/ISO. ODM may require new certification depending on modification scope | |
All Winkonlaser OEM devices are manufactured in the same FDA 510(k) cleared, ISO 13485 certified facility as our own branded products. For OEM orders, the existing certifications apply — your branded device carries the same regulatory clearances as the underlying Winkonlaser model. For ODM orders requiring new certifications, our regulatory team can compile and submit the technical documentation package.
| Certification | OEM | ODM |
|---|---|---|
| FDA 510(k) | Applies to DM60/DM40P base models | New 510(k) may be required |
| CE MDD | Applies — 9 product categories certified | May require new CE application |
| ISO 13485 | Applies — all devices manufactured under this QMS | Applies — facility QMS covers ODM production |
| IEC 60601-1 | Applies to base models | New CB test may be required for modified designs |
Full certification details and verification → Certifications & Compliance Center
1 unit for most models with basic OEM (logo swap only). 3–5 units for standard OEM (full branding — custom color, UI language, packaging). 5–20 units for ODM (hardware/software customization). MOQ varies by product line; contact us for model-specific minimums.
Basic OEM: 5–7 days (logo + UI branding). Standard OEM: 7–10 days (full branding + custom UI language). ODM: 30–90 days depending on design complexity. Add 3–7 days for air freight or 15–30 days for sea freight. Total timeline: approximately 2–3 weeks for a standard OEM order from consultation to delivery.
Yes — for OEM orders where the device hardware is unchanged. The FDA 510(k) and CE MDD certificates belong to Winkonlaser as the legal manufacturer. Your branded device is manufactured on the same production line, with the same components, under the same quality system. The device label will show "Manufactured by Winkonlaser" with your brand name as the distributor. For ODM orders with hardware modifications, new or amended certifications may be required — our regulatory team can guide you through this process.
All OEM/ODM devices are covered by Winkonlaser's 2-year warranty on the laser bar/tube and power supply. Support includes: remote video diagnosis and repair guidance, spare parts shipped within 48 hours, access to our technical training library, and optional on-site technician dispatch. We recommend stocking $500–1,000 in common spare parts (handpiece, cooling pump, power supply) for your region to minimize downtime.
Contact us with: (1) the product model(s) you're interested in, (2) your target market/country, (3) your preferred OEM tier (basic/standard/ODM), (4) your estimated first order quantity. We'll respond within 24 hours with a detailed quotation including customization options, pricing, lead time, and shipping costs. A sample branded unit can be produced for your approval before full production begins.
Tell us which product you're interested in and your target market. We'll send a customized OEM/ODM quotation within 24 hours.
Start Your OEM Inquiry