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UltraClear Laser System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K233803

by Acclaro Corporation

Identifiers

510(k) Number
K233803 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 UltraClear Laser System is a Fractional Laser Device (Product Code: GEX) designed for dermatological soft tissue ablation, coagulation, and resurfacing. It employs a 2910 nm laser to deliver controlled energy for skin resurfacing, collagen remodeling, and treatment across various skin types through fractional ablation.

This transportable system features a 15-inch touch screen for user-defined settings, integrated laser module, scanner drivers, and software controls. Supplied as a reusable medical device, it is cleared under FDA 510(k) K233803 and MDR, intended for use in clinical settings by trained professionals. No sterility or single-use designation is specified in the regulatory data.

Frequently asked questions

What types of skin treatments can the UltraClear Laser System be used for, and how does the 2910 nm laser wavelength contribute to its effectiveness?

The UltraClear Laser System is designed for dermatological procedures like skin resurfacing, collagen remodeling, and controlled soft tissue ablation. The 2910 nm laser wavelength is specifically chosen for its ability to penetrate the skin effectively, enabling precise fractional ablation. This wavelength is particularly well-suited for treating conditions like acne scars, wrinkles, pigmentation issues, and other skin texture irregularities by stimulating collagen production and promoting tissue regeneration.

Is the UltraClear Laser System intended for single-use or reusable applications, and what does this mean for maintenance and cleaning?

The UltraClear Laser System is classified as a reusable medical device, meaning it is designed for repeated use in clinical settings after proper cleaning and maintenance. Since it is not sterile upon delivery, facilities must follow manufacturer-recommended protocols for disinfection and sterilization between uses to ensure safety and performance. This also implies that the system requires regular upkeep of its components, including the laser module and touch screen, to maintain optimal functionality.

How does the user interface of the UltraClear Laser System enhance its usability for dermatological procedures?

The UltraClear Laser System features a 15-inch touch screen interface that allows trained professionals to customize settings directly, ensuring precise control over laser parameters. This user-friendly design enables real-time adjustments to energy delivery, pulse duration, and other treatment variables, which are critical for tailoring procedures to different skin types and treatment goals. The integrated software and scanner drivers further streamline workflow, improving efficiency and accuracy during dermatological interventions.

What does the advisory committee classification (SU) and product code (GEX) indicate about the intended clinical use of this device?

The advisory committee classification (SU) under the General, Plastic Surgery category suggests that the UltraClear Laser System was reviewed by a panel focused on surgical and aesthetic procedures, reinforcing its dermatological and soft tissue applications. The product code (GEX) categorizes it as a fractional laser device, which aligns with its intended use for controlled skin resurfacing, coagulation, and collagen remodeling—commonly employed in cosmetic and reconstructive dermatology.

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: K233803 FDA 510 (k) - UltraClear Laser System (N/A), UltraClear® Laser Cold Fiber | Laser Skin Resurfacing, UltraClear Laser System (N/A) (K233803) — FDA 510(k) | Innolitics, UltraClear Laser System (N/A) - FDA 510(k) K233803

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Acclaro Corporation

Sources (2)

  • FDA 510(k) K233803 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026