Certifications & Regulatory Compliance
Every Winkonlaser device is designed, manufactured, and certified to international medical device standards. All certificates are independently verifiable at their respective issuing body databases. Below is a complete record of Winkonlaser's active certifications.
FDA 510(k) Premarket Notification
K241860 — Class II Medical Device Clearance
Covered Products:
Verify in FDA DatabaseCE Marking — MDD 93/42/EEC (9 Product Certificates)
MDD 93/42/EEC — Medical Device Directive
Winkonlaser holds 9 individual CE certificates under MDD 93/42/EEC, each covering a specific product category. All certificates are registered with ENC Lab (Notified Body) and independently verifiable by entering the registration number at the ENC Lab search portal.
| Product Category | MDD CE Image | MDD Registration No. | EMC CE Image | EMC Registration No. | Winkonlaser Product(s) |
|---|---|---|---|---|---|
| Long Pulse Laser |  |
ENC231217GZ52 | — | — | CL300 |
| Picosecond Laser |  |
ENC231217GZ53 | — | — | EL950, EL400 |
| Cryolipolysis |  |
ENC231217GZ54 | — | — | HS1000C |
| EMS Sculpting (HIEMT) |  |
ENC231217GZ55 |  |
ZKT-2020050602C | FE60 |
| IPL Multifunction |  |
ENC231217GZ56 | — | — | ML600 |
| Cold Plasma |  |
ENC2511116GZ91 | — | — | Cold Plasma Machine |
| HIFU |  |
ENC231217GZ57 | — | — | HU700 |
| CO₂ Fractional Laser |  |
ENC231217GZ58 | — | — | FC300 |
| 808nm Diode Laser |  |
ENC231217GZ59 |  |
ENC231216GZ81-1 | DM60, DM40P |
Click any certificate image to enlarge. Hover to zoom. All MDD CE certificates are verifiable at ENC Lab. EMC CE certificates: 808nm Diode Laser verified at ENC Lab; EMS Sculpting verified at ZKT Lab.
Verify MDD CE at ENC LabISO 13485:2016 — Medical Device Quality Management System
ISO 13485:2016
Covered Products: All Winkonlaser devices — DM60, DM40P, CL300, ML600, HU700, TM80, FE60, HS1000C, EL950, EL400, FC300
Verify ISO 13485 CertificateIEC 60601-1 — Medical Electrical Equipment Safety
IEC 60601-1 (Ed. 3.1)
CB Test Report and Certificate available upon request.
How to Independently Verify Winkonlaser Certificates
For FDA 510(k): FDA PMN Database
Go to FDA PMN Database. Enter K-number K241860. Verify: Applicant = Winkonlaser, Device = Diode Laser Hair Removal System, clearance date is valid.
For CE MDD: ENC Lab Certification Portal
Go to ENC Lab Search. Enter any of the 9 registration numbers above (e.g., ENC231217GZ59 for 808nm Diode Laser). Verify: product name matches, manufacturer = Winkonlaser, certificate is active.
For ISO 13485: Issuing Body Database
Request the certificate number from Winkonlaser. Go to the issuing body's public verification portal (SGS CertSearch, TÜV Certificate Check, BSI VerifEye Directory, etc.). Verify: certificate scope includes "design and manufacture of laser equipment," manufacturer name matches, expiry date is current.
4 Common Certificate Scams in the Aesthetic Laser Industry
"FDA Registered" — not the same as "FDA Cleared"
Any manufacturer can pay a ~$5,000 annual fee to register their facility with the FDA. This is a facility listing, not a device review. FDA 510(k) clearance requires submitting clinical and technical data for FDA review. A K-number proves clearance; "FDA Registered" alone does not. Always ask for the K-number.
CE Mark without a Notified Body Registration Number
A valid CE certificate for medical devices is issued by a Notified Body and has a unique registration number (e.g., ENC231217GZ59). A CE mark without a verifiable registration number is self-declared — valid only for non-medical products, not for aesthetic laser devices. Check at the issuing body's database.
Certificate belongs to a different company or model
Some manufacturers show a real certificate — but it belongs to a different company, a different device model, or a previous product version. Cross-check: manufacturer name, device name, and model number must all match the certificate. A certificate for "Model X" does not cover "Model Y" even if they look identical.
Expired or superseded certificates
CE certificates under MDD (93/42/EEC) have a defined validity period. Always check the issue date and expiry date on the certificate. An expired certificate is not valid for placing products on the EU market. ISO 13485 certificates typically have a 3-year validity; check both dates.
Frequently Asked Questions
Yes. The AresLite DM60 and DM40P diode laser systems hold FDA 510(k) clearance under K241860. This is a Class II medical device clearance. You can verify at the FDA PMN Database. For other product lines (HIFU, CO2, EMS, cryolipolysis), regulatory classifications vary by market. Contact us for product-specific clearance status in your country.
Go to ENC Lab Certification Search. Enter the registration number from the certificate (e.g., ENC231217GZ59 for 808nm Diode Laser). Verify that: (1) the manufacturer name is Winkonlaser, (2) the product description matches, and (3) the certificate is within its validity period. All 9 Winkonlaser CE certificates are registered and verifiable through this portal.
The underlying device certifications belong to Winkonlaser as the legal manufacturer. When you white-label, the device is manufactured in our certified facility using the same components, quality system, and design dossier. FDA clearance and CE certificates are associated with the manufacturer, not the distributor brand. If you need device registration under your own company name, our regulatory team can assist with compiling the application — existing technical documentation can support your filing, significantly reducing time to market.
FDA 510(k) clearance does not expire as long as annual establishment registration is maintained. CE MDD certificates are periodically reviewed by the Notified Body. ISO 13485 certificates are valid for 3 years with annual surveillance audits. IEC 60601-1 test reports are updated when the device is significantly modified or the standard is revised. Winkonlaser's quality and regulatory team manages all renewal cycles and surveillance audits.
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