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.
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. All MDD CE certificates are verifiable at ENC Lab. EMC CE: 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.
For CE MDD: ENC Lab Certification Portal
Go to ENC Lab Search. Enter any of the 9 registration numbers (e.g., ENC231217GZ59). Verify: product name, 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. Verify: 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. FDA 510(k) clearance requires submitting clinical and technical data for FDA review. A K-number proves clearance; "FDA Registered" alone does not.
CE Mark without a Notified Body Registration Number
A valid CE certificate for medical devices has a unique registration number (e.g., ENC231217GZ59). A CE mark without a verifiable registration number is self-declared — not valid for aesthetic laser devices.
Certificate belongs to a different company or model
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
Always check the issue date and expiry date. An expired certificate is not valid for placing products on the EU market. ISO 13485 certificates typically have a 3-year validity.
Frequently Asked Questions
Yes. The AresLite DM60 and DM40P hold FDA 510(k) clearance under K241860. Verify at the FDA PMN Database. For other product lines, contact us for product-specific clearance status in your country.
Go to ENC Lab Certification Search. Enter the registration number (e.g., ENC231217GZ59 for 808nm Diode Laser). Verify manufacturer name, product description, and validity period.
The underlying device certifications belong to Winkonlaser as the legal manufacturer. FDA and CE certificates are associated with the manufacturer, not the distributor brand. If you need registration under your own company name, our regulatory team can assist.
FDA 510(k) clearance does not expire as long as annual establishment registration is maintained. CE MDD certificates are periodically reviewed. ISO 13485 certificates are valid for 3 years with annual surveillance audits.
Need Regulatory Documentation for Your Market?
Request our full regulatory dossier: certificate copies, technical documentation, test reports, and clinical evaluation.
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