Medical devices, registered and documented
Every machine on this page is registered with the MHRA by us, as the UK Responsible Person. That is a legal role with named obligations, not a marketing badge.
What actually makes something a medical device
It is not about how expensive the machine is, or how clinical it looks. Under the rules the MHRA applies, two things decide it: what the device is intended to do, and how it does it.
Intended purpose
The maker’s stated purpose for the device, including the claims made about it in labelling, instructions and advertising. If a machine is put on the market to diagnose, prevent, monitor, treat or alleviate a condition, that points towards a medical device.
Mode of action
A medical device must achieve its principal intended action by physical or mechanical means. If the main action is pharmacological, metabolic or immunological, it is not a medical device.
Source: MHRA guidance on borderline products, gov.uk
This is a plain-English summary, not legal advice. The full guidance is on gov.uk.
What a UK Responsible Person actually does
If a manufacturer is based outside the UK, they must appoint a UK Responsible Person to place devices on the Great Britain market. For the machines on this page, that person is Carla Cooper-Gale, and the obligations sit with her personally.
Registers the devices
Every device is registered with the MHRA before it can lawfully be placed on the Great Britain market. Without that registration it cannot be sold here at all.
Holds the documentation
The declaration of conformity and the technical documentation have to be available for the MHRA to inspect, and evidence of conformity provided when they ask for it.
Passes on complaints
Complaints and incident reports from practitioners and clients go back to the manufacturer. If a manufacturer will not put things right, the relationship ends and the MHRA is told.
Summarised from the MHRA guidance Regulating medical devices in the UK.
Medical devices we supply
Prices exclude VAT. Every one of these is registered with the MHRA by Skintastic Aesthetic Supplies Ltd as UK Responsible Person, and supplied with installation and training.
DPL4 Quad Wavelength ComboDiode laser, IPL and Nd:YAG in one platform. Hair removal, skin rejuvenation and carbon peel.£21,999 excl. VAT
Med-860 RENO Q-Switched Nd:YAGFive wavelengths as standard. Tattoo removal, pigmentation, nail treatment and carbon facials.£17,999 excl. VAT
LD1 Diode Laser SystemQuad wavelength diode with cooled CMAX handpiece, for professional hair removal.£14,999 excl. VAT
ADPL-2 Diode and IPL Platform800W quad wavelength diode plus IPL and SHR in one portable unit. Seven functions.£11,999 excl. VAT
2-in-1 Portable Diode and Nd:YAGDiode hair removal and Q-switched Nd:YAG tattoo removal from a single portable platform.£11,499 excl. VAT
FOCXEL CO2 Fractional Laser10600nm fractional CO2 for resurfacing, scarring and aesthetic gynaecology.£9,999 excl. VAT
ALD1 CH Quad Wavelength Diode800W diode with four wavelengths and intelligent handpiece recognition.£8,999 excl. VATWhat comes with every machine
The documentation
Declaration of conformity and instructions for use, supplied with the device. If we cannot get correct documentation from a manufacturer, we do not sell the machine.
Installation and training
Engineer installation and setup, plus operator training on your own machine in your own room. Training routes depend on your existing qualifications.
Support and warranty
Technical support from Southampton. Warranty and servicing terms are confirmed in writing before you commit to anything.
What “registered” does and does not mean
The MHRA does not approve or endorse devices
Registration means a device has been notified to the regulator so that it can lawfully be placed on the Great Britain market. It is a legal requirement, not a quality award. If a supplier tells you a machine is “MHRA approved” or “MHRA certified”, they are describing something that does not exist.
We say registered, because that is what it is.
Advertising guidance from the Committee of Advertising Practice is explicit that marketers should not state or imply that a device has been approved or certified by the MHRA.
CE and UKCA marking
Both are currently accepted in Great Britain. Devices certified under the older EU directives are accepted until the certificate expires or 30 June 2028, whichever comes first. Devices certified under the EU Medical Devices Regulation are accepted until 30 June 2030.
Dates from MHRA guidance, gov.uk. We will tell you which marking your machine carries and when it runs out.
Our manufacturers
Our devices are built by established manufacturers who hold ISO 13485 quality management certification. That certification belongs to them, not to us, and we say so.
We import, register and support. We do not manufacture.
Ask us anything before you buy
Come and see a machine powered up at The Avenue, or ask for a free video demonstration. You will be speaking to the person whose name is on the MHRA registration.
