Short answer: In the EU, a seller’s claim that one aesthetic laser has both a medical use and a cosmetic use should trigger two lines of evidence, not a single all-purpose certificate. MDCG 2023-5 explains that a dual-purpose product must meet the requirements applicable to its medical purpose and those applicable to its non-medical purpose. Where requirements differ, the guidance calls for the more stringent requirement to be applied. A buyer should map the exact indications, settings, accessories and risk controls for each use before treating an offer as suitable for both.
What dual purpose means in the guidance
The Medical Device Coordination Group published its guidance on Annex XVI qualification and classification in December 2023. It is interpretive guidance, not a new 2026 rule or a product approval. Section 3.3 addresses devices for which the manufacturer claims both a medical and non-medical intended purpose. It says the applicable requirements are cumulative. Where the purposes are never achieved simultaneously in one patient, the medical-device rules and common specifications may be applied separately to those uses, but controls must also be considered in combination because a safeguard for one use can create a risk in the other.
The document even illustrates this with laser equipment. A wavelength restriction suitable for a medical purpose could damage skin if it is then used for a cosmetic purpose requiring different emission characteristics. Conversely, a limit set for the cosmetic purpose may undermine the medical performance. The point is not to recommend a wavelength or setting. It is that two claims on one brochure do not become safe merely because a device has a switch between modes. A manufacturer needs a coherent intended-purpose statement and evidence for the interactions.
What a buyer should request
Ask for the exact model and configurations offered in the EU, not a family brochure. Request a matrix linking each claimed indication to its intended users, accessories, software mode, operating instructions, warnings and applicable conformity records. Ask whether the two uses share risk controls and how a user is prevented from selecting an inappropriate mode. Check whether clinical and non-clinical evidence support the corresponding claims, and whether servicing or software updates could change the boundaries. If a distributor presents only a generic CE image, ask the legal manufacturer to identify the regulatory route and technical documentation behind both purposes.
This is different from deciding whether a single-purpose cosmetic light source falls within Annex XVI at all. Qualification comes before classification, as the guidance says. It is also different from treating radiofrequency as a type of laser: the source notes RF can be electromagnetic radiation, but its technology and intended effect need their own assessment. A buyer should avoid moving a clinical claim from one device configuration to another without fresh review.
Limits
MDCG guidance is not legally binding and the example does not classify any TUOKE device. The EU MDR, common specifications and national implementation require a product-specific review; this article is not legal or clinical advice. No TUOKE optical device, approval or performance result is asserted here. Before a launch, obtain the manufacturer’s complete documentation and qualified EU regulatory advice for both claimed purposes. The source is older background for a current diligence decision, not breaking industry news.
Continue with the TUOKE optical aesthetic equipment insights for adjacent questions about safety and claims.
Source
Medical Device Coordination Group, MDCG 2023-5, Guidance on qualification and classification of Annex XVI products, December 2023; reviewed 15 October 2026.