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xeo+ Family

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K233237

by Cutera, Inc.

Identifiers

510(k) Number
K233237 FDA 510(k)
FDA Product Code
GEX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The xeo+ Family is a class of laser-based devices designed for non-ablative skin remodeling and tissue tightening. These devices utilize fractional laser technology to target collagen production in the skin, promoting rejuvenation and improvement of skin texture, tone, and elasticity without damaging the epidermis.

The xeo+ Family is supplied as a reusable medical device intended for use in clinical settings such as dermatology offices and cosmetic surgery clinics. Devices in this family are not single-use and require proper sterilization between procedures. Authorized for use in the United States under FDA 510K clearance (K233237) and compliant with MDD and MDR directives, these devices are categorized under product code GEX for general plastic surgery applications.

Frequently asked questions

What types of clinical settings is the xeo+ Family intended for, and how is it supplied?

The xeo+ Family is designed for use in clinical settings like dermatology offices and cosmetic surgery clinics. It is supplied as a reusable medical device, meaning it must be properly sterilized between procedures to ensure patient safety and device integrity.

How does the xeo+ Family differ from single-use laser devices, and what does this mean for my practice?

Unlike single-use devices, the xeo+ Family is not single-use and requires sterilization between patients. This means your practice must have a validated sterilization process in place, such as autoclaving or chemical sterilization, to maintain compliance and hygiene standards before each use.

What regulatory pathways does the xeo+ Family follow, and how does this impact its use in the U.S.?

The xeo+ Family is cleared under FDA 510(k) clearance (K233237) as substantially equivalent to a predicate device, with a decision categorized under General Plastic Surgery (GEX). This means it is legally authorized for use in the U.S. for non-ablative skin remodeling and tissue tightening, as described in the device’s intended purpose.

What is the primary clinical application of the xeo+ Family, and how does fractional laser technology work in this context?

The xeo+ Family uses fractional laser technology to stimulate collagen production in the dermis without damaging the epidermis, improving skin texture, tone, and elasticity. It is specifically designed for non-ablative skin remodeling and tightening, making it suitable for procedures like rejuvenation and mild skin laxity correction.

Are there different models or configurations within the xeo+ Family, and if so, how might they differ?

The provided data does not specify distinct models or configurations beyond the xeo+ Family classification. However, fractional laser devices often vary by wavelength, spot size, or energy settings to target different skin concerns. For precise details on available models or technical specifications, you would need to consult Cutera’s official product documentation or contact their support team.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cutera, Inc.

Sources (2)

  • FDA 510(k) K233237 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026