Compliance

Certifications, clearance, and what we'll put in writing

Buying capital equipment means knowing two separate things: that it was built under a recognised quality system, and that this specific model is legal to operate where you practise. Those aren't the same question, and we don't blur them.

Manufacturing

Quality-system certifications

These are held at the manufacturing level and describe how the equipment is built, audited and documented. They apply to the production process — not to any individual clearance.

Quality management ISO 13485

The international quality-management standard specific to medical device manufacturing. Covers design controls, traceability and post-market surveillance.

Multi-country audit MDSAP

The Medical Device Single Audit Program — one audit recognised by multiple national regulators, including the US, Canada and Australia.

Electrical safety IEC test reports

Independent test reports covering electrical safety and electromagnetic compatibility for the platform as manufactured.

Europe CE / MDR

Conformity marking for the European market under the Medical Device Regulation. Applies per device family.

Australia TGA

Therapeutic Goods Administration registration, required for supply into the Australian market.

Canada Health Canada MDL

Medical Device Licence, required for sale into Canada. Issued per device and per class.

United States

Clearance is granted per device, not per company

Most aesthetic laser and energy-based systems are Class II devices in the United States. That means each individual model is reviewed and cleared for its own specific indications through a 510(k) premarket notification — and a clearance held by one platform says nothing about any other platform.

For that reason we don't display a single site-wide regulatory badge. Every device page on this site carries its own clearance status instead, so you can see exactly where a particular platform stands before you ask us for a number.

What you'll see on a device page

FDA 510(k) cleared · K000000 The model is cleared, and we can produce the documentation on request.

Clearance documentation supplied with quote We'll confirm this platform's exact status in writing before you commit to anything.

CE marked — not offered for US sale Available in other markets; we will not supply it into the United States.

If a platform's status is anything other than cleared, you'll see that plainly rather than finding out after purchase.

Your practice

Indications and scope of practice

A device being cleared does not mean every use of it is cleared. Clearance is granted for defined indications, and the treatments you can legally offer also depend on your licence, your state's regulations and your supervising physician arrangements.

We supply equipment and documentation. Determining appropriate clinical use — and staying inside both the cleared indications and your own scope of practice — remains the responsibility of the purchasing practitioner. If you're unsure whether a platform supports the service you want to offer, ask us before you buy and we'll tell you plainly.

Nothing on this site should be read as clinical, legal or regulatory advice.

With every quote

The paperwork you get before you commit

Specification sheet

The full technical specification for the exact configuration being quoted.

Regulatory documentation

Clearance or certification status for that specific model, in writing.

Landed cost

Equipment, freight, duties and installation — the total, not the headline.

Warranty & support terms

Coverage period, what's included, parts and consumable availability.