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CoolGlide Aesthetic Lasers

FDA 510(k)

Class II (US FDA 510(k))

510(k) K132185

by Cutera, Inc.

Identifiers

510(k) Number
K132185 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 CoolGlide Aesthetic Lasers are a family of medical devices classified under laser and light-based systems for aesthetic and dermatological applications. These devices utilize multiple wavelengths—755 nm Alexandrite, 1064 nm Nd:YAG, 532 nm Nd:YAG, and pulsed light—to selectively target and treat skin and vascular tissues through controlled photothermolysis. Their design enables precision treatment of pigmented lesions, hair removal, vascular anomalies, and skin rejuvenation. The system is engineered to deliver energy in a manner that minimizes collateral damage to surrounding tissues while achieving clinical outcomes.

The CoolGlide Aesthetic Lasers are intended for use in surgical and aesthetic settings by qualified medical professionals, including dermatologists and plastic surgeons. Supplied as a reusable medical device, the system requires proper calibration and maintenance to ensure safety and efficacy. No specific sterility claims are stated, but adherence to standard infection control protocols is implied for reusable components. The devices are regulated under FDA 510(k) clearance (K132185) and fall under the product code GEX, reflecting their classification in the advisory committee for general and plastic surgery applications.

Frequently asked questions

What wavelengths does the CoolGlide Aesthetic Lasers system use for treatment?

The CoolGlide Aesthetic Lasers utilize four distinct wavelengths: 755 nm Alexandrite, 1064 nm Nd:YAG, 532 nm Nd:YAG, and pulsed light. Each wavelength is designed to selectively target specific skin and vascular tissues through controlled photothermolysis, enabling precise treatment of pigmented lesions, hair removal, vascular anomalies, and skin rejuvenation while minimizing damage to surrounding areas.

Is the CoolGlide Aesthetic Lasers system reusable or single-use?

The CoolGlide Aesthetic Lasers system is supplied as a reusable medical device. Reusable components require proper calibration and maintenance to ensure safety and efficacy. Standard infection control protocols must be followed during use to maintain sterility and prevent cross-contamination between patients.

What types of treatments can this laser system perform?

This system is intended for aesthetic and dermatological applications, including the treatment of pigmented lesions, hair removal, vascular anomalies (such as spider veins), and skin rejuvenation. The multi-wavelength design allows clinicians to select the most appropriate setting for each condition, ensuring targeted and effective results.

Who is authorized to use the CoolGlide Aesthetic Lasers?

The CoolGlide Aesthetic Lasers are designed for use by qualified medical professionals, such as dermatologists and plastic surgeons, in surgical and aesthetic settings. Their advanced technology requires specialized training to operate safely and effectively, ensuring optimal clinical outcomes.

How is the CoolGlide Aesthetic Lasers system regulated?

The CoolGlide Aesthetic Lasers have received FDA 510(k) clearance under the product code GEX, which falls under the advisory committee for general and plastic surgery applications. The system is classified as substantially equivalent to a predicate device and is regulated under traditional clearance procedures.

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. Sources consulted: CUTERA | Bringing New Energy and New Solutions to Aesthetics, Family of CoolGlide Aesthetic Lasers (K153671) — FDA 510 (k ..., What is Cutera CoolGlide Laser System - Benefits & Uses, Cutera Aesthetic Lasers

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cutera, Inc.

Sources (1)

  • FDA 510(k) K132185 24 fields · synced Oct 1, 2026