Requirements differ
There is no single certification that applies universally to every aesthetic device or every market.
Mico Aes · Product Documentation
Certificazioni & Conformità
Mico Aes provides certification, technical, and regulatory documentation for professional aesthetic equipment according to the specific product model and destination market.
Because regulatory requirements vary by device, intended use, classification, and country, certification and regulatory status should always be verified for the exact equipment you are considering.
Start with the exact model
Compliance Information for Professional Aesthetic Equipment
Professional aesthetic equipment may be subject to different regulatory, safety, electrical, quality-management, and import requirements depending on where the equipment will be sold or used.
Documents are product-specific
At Mico Aes, available documentation is provided according to the specific machine, manufacturing source, product classification, intended use, and destination market.
More than certificates
This may include applicable certificates, declarations, technical specifications, user documentation, test reports, and supporting import documentation.
Importante: Certifications, registrations, clearances, approvals, and regulatory documentation vary by product model and destination market. Please contact us to verify the documentation available for the exact model you are considering.
Manufacturing documentation
Quality Management
ISO Quality Management Information
Quality management documentation may be available for applicable manufacturers and product lines.
Depending on the product and manufacturing facility, relevant documentation may include applicable ISO quality-management certifications.
For products subject to medical-device quality-management requirements, ISO 13485 documentation may be available where applicable.
Because certification scope can differ by manufacturer, facility, product category, and certification body, buyers should request documentation applicable to the specific equipment they intend to purchase.
Model-specific documents
Product Certifications & Safety Documentation
Available product documentation depends on the equipment model and target market.
Documentation may include, where applicable:
- CE-related documentation
- Declarations of Conformity
- Electrical safety documentation
- EMC documentation
- RoHS-related documentation
- Product test reports
- Specifiche tecniche
- Manufacturer information
- Product labels
- Manuali utente
- Other market-specific supporting documents
The availability of one document should not be interpreted as evidence that every Mico Aes product has the same regulatory status.
Stati Uniti
U.S. Regulatory Information
Aesthetic equipment sold or used in the United States may be subject to requirements of the U.S. Food and Drug Administration (FDA) and other federal, state, or local authorities depending on the device and intended use.
It is important to distinguish between different FDA regulatory terms.
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FDA Establishment Registration
Certain establishments involved in the manufacture or distribution of medical devices may be required to register with the FDA. Establishment registration relates to the establishment and does not, by itself, mean that an individual device is FDA approved or FDA cleared.
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FDA Device Listing
Applicable devices may be listed with the FDA by registered establishments. Device listing is not the same as FDA approval or 510(k) clearance.
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510(k) Clearance
Certain medical devices require a premarket notification under Section 510(k). When the FDA determines that a device is substantially equivalent to a legally marketed predicate device, the device may receive 510(k) clearance. Where applicable, 510(k) information should be verified for the specific device and intended use.
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Approvazione della FDA
FDA approval generally applies to regulatory pathways where formal premarket approval is required, such as certain higher-risk medical devices.
The terms FDA registered, FDA listed, FDA cleared, E FDA approved should not be used interchangeably.
Before Purchasing Equipment for the United States
If U.S. regulatory status is important for your business, please provide us with the exact machine model you are considering. We can provide the available regulatory and technical information for that specific product so that you can evaluate it against your purchasing and local compliance requirements.
European Union
European Regulatory Information
Aesthetic and medical equipment placed on the European market may be subject to different requirements depending on product classification, intended purpose, and applicable European legislation.
Depending on the specific product, relevant documentation may include:
- CE-related documentation
- EU Declaration of Conformity
- Manufacturer information
- Applicable test reports
- Product labeling
- User instructions
- Other supporting technical documentation
For devices falling within the scope of European medical-device legislation, additional requirements may apply.
CE and MDR Are Not the Same Thing
A CE marking alone should not automatically be interpreted as evidence of compliance with the EU Medical Device Regulation (MDR).
Where MDR compliance is required, the regulatory status and supporting documentation should be verified for the exact product.
If MDR documentation is an essential purchasing requirement for your clinic, distributor business, or target market, please tell us before placing the order so that we can confirm the documentation available for the specific model.
Products Without an Intended Medical Purpose
Certain product groups without an intended medical purpose are also covered by MDR Annex XVI. For aesthetic equipment, the listed groups include specified high-intensity electromagnetic-radiation equipment for skin treatment, such as lasers and intense pulsed light (IPL) equipment, and equipment intended to reduce, remove, or destroy adipose tissue.
Whether a specific product falls within scope depends on its exact intended purpose and product details. Verify the requirements for the specific model and market.
EU COMMISSION: COMMON SPECIFICATIONS FOR ANNEX XVI PRODUCTS →
Beyond certificates
Documentazione tecnica
Professional buyers often require more than a certificate.
Depending on the equipment and order, available supporting documentation may include:
Product Information
- Technical specification sheet
- Product configuration
- Model information
- Product photographs
- Labels and identification information
Operating Documentation
- Manuale dell'utente
- Installation instructions
- Operating guidance
- Maintenance information
- Troubleshooting guidance
Trattamento & Training Resources
- Materiali per la formazione degli operatori
- Protocolli di trattamento
- Parameter guidance
- Contraindications information
- Safety guidance
- Pre- and post-treatment information
Technical & Compliance Documentation
- Available certificates
- Declarations
- Applicable test reports
- Electrical information
- Packing information
- Other product-specific technical documents
Document availability varies by product.
For business customers
Documentation for Importers & Distributori
Distributors, importers, private-label brands, and professional buyers may require additional documentation before introducing equipment into their target market.
We can work with business customers to identify the available documentation for selected products.
Depending on the product and project, this may include:
- Manufacturer information
- Product specifications
- Product labeling information
- Manuali utente
- Available certificates
- Declarations of Conformity
- Applicable test reports
- Packing lists
- Commercial invoices
- Product configuration information
- OEM / private-label documentation
- Other available shipping or import documentation
Regulatory requirements differ between markets. Importers and distributors remain responsible for determining the requirements applicable to their intended market and business activities.
Plan early
OEM & Private Label Compliance Considerations
Private-label projects may require more than adding a customer’s logo to an existing machine.
Depending on the market and product classification, changes to branding, labeling, manufacturer information, packaging, intended use, or product configuration may affect documentation and regulatory responsibilities.
For OEM and private-label projects, compliance requirements should therefore be discussed during product selection rather than after production has been completed.
Raccontaci:
- Your target country or region
- Product category
- Intended business model
- Required certifications or documentation
- Branding requirements
- Expected order quantity
Our team can then confirm what documentation and customization support is available for the selected product.
Make your request specific
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How to Request Documentation
To help us identify the correct documents, please provide:
Product Name or Model
Tell us exactly which machine you are considering.
Destination Country
Regulatory and import requirements differ between markets.
Business Type
For example: clinic, med spa, salon, distributor, importer, or private-label brand.
Documents Required
For example: CE documentation, ISO information, technical specifications, user manual, test reports, or other requested documents.
Intended Application
Tell us how and where you intend to market or use the equipment.
We will then confirm which documentation is available for the specific product.
Common questions
Domande frequenti
Are all Mico Aes machines CE certified?
Certification status varies by product model. Please request the applicable documentation for the exact machine you are considering rather than assuming that one certificate applies to the entire product range.
Are all Mico Aes machines FDA approved?
No blanket FDA claim should be applied to the entire product range. U.S. regulatory status depends on the specific device and intended use.
FDA establishment registration, device listing, 510(k) clearance, and FDA approval are different regulatory concepts.
Please contact us for information applicable to the specific model you are considering.
Does FDA registration mean a machine is FDA approved?
No. Establishment registration does not mean that a specific device has received FDA approval or 510(k) clearance.
Does FDA listing mean a device is FDA cleared?
Not necessarily. Device listing and 510(k) clearance are different regulatory concepts.
Does a CE certificate mean the machine is MDR certified?
Not automatically. The applicable European regulatory framework depends on the product, classification, intended purpose, and supporting documentation.
If MDR compliance is required, request documentation for the exact model before purchasing.
Can you provide documents before I place an order?
Available product and regulatory documentation can be discussed during the purchasing process. The documents that can be provided before an order is confirmed depend on the specific product, document type, and project requirements.
Can you provide documentation for customs clearance?
Commercial and shipping documentation can be provided according to the order and shipping arrangement. Additional regulatory or import requirements depend on the destination country.
Can distributors request compliance documents before selecting products?
Yes. If certification or regulatory requirements are essential for your market, tell us the target country and required documentation during product selection so that we can identify suitable products before you place an order.
Verify before you buy
Verify Before You Buy
Regulatory requirements differ between products and markets.
Before purchasing professional aesthetic equipment, verify the certification, regulatory status, technical documentation, and local operating requirements applicable to the exact model and intended use.
Tell us which machine you are considering and where you plan to use or distribute it.
We will help you identify the documentation available for that product.