{"id":3070,"date":"2024-12-02T20:38:01","date_gmt":"2024-12-02T20:38:01","guid":{"rendered":"https:\/\/veraqueconsulting.com\/co\/?p=3070"},"modified":"2024-12-02T20:38:19","modified_gmt":"2024-12-02T20:38:19","slug":"classification-and-grouping-of-laser-medical-devices-in-colombia","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/co\/classification-and-grouping-of-laser-medical-devices-in-colombia\/","title":{"rendered":"Classification and Grouping of Laser Medical Devices in Colombia"},"content":{"rendered":"

The incorporation of laser technology to medical devices has come to play a crucial role in a diverse range of healthcare applications. Beyond their association with cosmetic procedures, many medical devices include lasers, transforming patient care and attention. From breaking down kidney stones to corneal correction, laser technology enhances healthcare and continues to evolve as technology in medical devices pushes forward.<\/span>\u00a0<\/span><\/p>\n

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In this article, we will discuss different types of medical devices that incorporate lasers as part of their structure, as well as general guidelines on <\/span>their classification and grouping in Colombia<\/span><\/b>.<\/span>\u00a0<\/span><\/p>\n

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Laser Medical Devices<\/span><\/b>\u00a0<\/span><\/h3>\n

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Medical devices that use built-in laser technology have been applied on a diverse array of products. It is of note that, if the device possesses mixed qualities regarding its use (such as a device that serves for hair removal or reduction, as well as being used for dermatologic or general surgery) or the specific treatment of a known disease (such as <\/span>alopecia areata<\/span><\/i>), they must be registered as medical devices, nonetheless.<\/span>\u00a0<\/span><\/p>\n

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Medical devices that add lasers to their structure use different types of sources to produce a laser beam. Some types of sources commonly used are: CO2, Nd:YAG, Er:YAG, diodes, holmium, alexandrite and argon. It is important to know that in spite of the source, most lasers are not catalogued as ionizing radiation, and thus, do not require the <\/span>specific authorizations for these kinds of medical devices<\/span>.<\/span>\u00a0<\/span><\/p>\n

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Classification and Grouping of Laser Medical Devices<\/span><\/b>\u00a0<\/span><\/h3>\n

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Medical devices with lasers are considered \u201cactive medical devices\u201d, <\/span>most of which interchange energy in a potentially dangerous way, taking into consideration their nature, density, and application place. As such, they are considered<\/span> Class IIb<\/strong> under the Colombian regulatory framework.<\/span>\u00a0<\/span><\/p>\n

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Common examples of this kind of devices are:<\/span>\u00a0<\/span><\/p>\n

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