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Image Vascular Laser

FDA 510(k)

Class II (US FDA 510(k))

510(k) K003046

by Sciton, Inc

Identifiers

510(k) Number
K003046 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 Image Vascular Laser is a carbon dioxide laser surgical instrument classified under § 878.4810, designed for cutting, destroying, or removing tissue through light energy emission. It is intended for use in general and plastic surgery as well as dermatology, providing precise vascular and skin treatments.

This device is supplied as a reusable laser system and is regulated under FDA 510(k) clearance (K003046) with a traditional review pathway. It is intended for clinical settings and adheres to regulatory standards for laser surgical instruments, with no specific sterility or MRI safety notes provided in the data. Storage and handling follow standard laser device protocols as outlined in the manufacturer’s instructions.

Frequently asked questions

What types of medical specialties can use the Image Vascular Laser, and why is it suited for those fields?

The Image Vascular Laser is designed for use in general surgery, plastic surgery, and dermatology. It is particularly suited for these fields because it emits precise light energy to cut, destroy, or remove tissue, making it ideal for vascular and skin treatments. Its versatility allows clinicians to perform procedures like skin resurfacing, vascular lesion removal, and other delicate surgeries where precision is critical.

Is the Image Vascular Laser a single-use device, or can it be reused? How does this affect its maintenance?

The Image Vascular Laser is a reusable laser system, meaning it is intended for repeated use in clinical settings after proper cleaning, maintenance, and sterilization as outlined in the manufacturer’s instructions. Since it is reusable, it requires adherence to standard laser device protocols for storage, handling, and servicing to ensure safety, performance, and compliance with regulatory standards.

What storage and handling guidelines should be followed for the Image Vascular Laser?

The Image Vascular Laser follows standard laser device protocols for storage and handling, as specified by the manufacturer. This typically includes keeping the device in a clean, dry environment away from direct sunlight or extreme temperatures, ensuring proper calibration, and storing it in its original packaging or designated case when not in use. Detailed instructions provided by Sciton, Inc. should be consulted for specific storage requirements.

What is the regulatory pathway for the Image Vascular Laser, and how does this affect its use in clinical settings?

The Image Vascular Laser was cleared through the FDA’s 510(k) traditional review pathway under clearance number K003046, meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance allows its use in clinical settings for cutting, destroying, or removing tissue in general, plastic surgery, and dermatology, provided the device is operated and maintained according to the manufacturer’s instructions and regulatory guidelines.

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: Welcome to Sciton Medical & Aesthetic Laser Technologies, IMAGE VASCULAR LASER by SCITON, INC. | FDA 510 (k) Summary, IMAGE VASCULAR LASER (K003046) — FDA 510 (k) | Innolitics, ClearV® by Sciton

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sciton, Inc

Sources (1)

  • FDA 510(k) K003046 24 fields · synced Sep 19, 2026