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Aramis II Dermatological Laser

FDA 510(k)

Class II (US FDA 510(k))

510(k) K032260

by Quantel Medical

Identifiers

510(k) Number
K032260 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 Aramis II Dermatological Laser is a medical device classified as a laser in medicine (product code GEX) under the FDA’s General and Plastic Surgery category. It is designed for precise tissue interaction, including incision, excision, ablation, and coagulation of soft tissue, as well as photocoagulation of vascular and pigmented dermatological lesions. Its erbium-based technology enables controlled energy delivery for dermatological procedures, such as vascular lesion treatment and pigmented lesion removal. The device operates within the parameters of a substantially equivalent (SE) 510(k) clearance, ensuring compliance with regulatory standards for soft tissue modification.

The Aramis II is supplied as a reusable medical laser system intended for use in clinical settings, including dermatology clinics and surgical suites. It requires proper training for operation and maintenance, adhering to manufacturer guidelines for sterility and safety protocols. The device is not classified as single-use and must be cleaned, disinfected, and stored according to established infection control procedures. Its regulatory clearance (FDA 510(k) K032260) confirms its compliance for intended dermatological applications, though MRI safety and specific sterilisation methods are not detailed in the available data.

Frequently asked questions

What is the Aramis II Dermatological Laser used for?

The Aramis II Dermatological Laser is designed for controlled tissue interaction in dermatological procedures, such as incision, excision, ablation, and coagulation of soft tissue. Its erbium-based technology is particularly effective for treating vascular lesions (e.g., spider veins) and pigmented lesions (e.g., tattoos or birthmarks). The device’s precision allows clinicians to perform photocoagulation with minimal collateral damage, making it suitable for procedures like vascular lesion removal and pigmented lesion ablation.

Is the Aramis II Dermatological Laser single-use or reusable?

The Aramis II is a reusable medical laser system, not intended for single-use. After each procedure, it must be thoroughly cleaned, disinfected, and maintained according to manufacturer guidelines to ensure sterility and safety. Proper infection control protocols are critical for reusable devices like this, as they are used across multiple patients in clinical settings such as dermatology clinics or surgical suites.

What regulatory clearance does the Aramis II Dermatological Laser hold?

The Aramis II Dermatological Laser holds FDA 510(k) clearance under the product code GEX, classified under General and Plastic Surgery. Its clearance is based on a substantially equivalent (SE) determination, meaning it meets regulatory standards for soft tissue modification procedures. The clearance (K032260) confirms its compliance for intended dermatological applications, though specific details like MRI safety or sterilization methods are not provided in the available data.

How should the Aramis II be stored and maintained?

The Aramis II requires proper storage and maintenance to ensure functionality and safety. After cleaning and disinfection, it should be stored in a clean, dry environment following manufacturer guidelines. Regular maintenance, including inspections and servicing, is essential to prevent malfunctions. Since it is a reusable device, adherence to infection control protocols—such as using approved disinfectants and avoiding cross-contamination—is mandatory to maintain sterility between uses.

What training is required to operate the Aramis II Dermatological Laser?

Operation of the Aramis II Dermatological Laser requires proper training to ensure safe and effective use. Clinicians must be familiar with the device’s controls, energy settings, and safety protocols, as well as the specific dermatological procedures it supports. Manufacturer-provided training materials and guidelines should be followed to minimize risks such as tissue damage or improper energy delivery. Training typically covers both technical operation and clinical applications to optimize patient outcomes.

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: ARAMIS II DERMATOLOGICAL LASER (K023734) — FDA 510 (k) | Innolitics, PDF K023734 - ARAMIS II DERMATOLOGICAL LASER - 510kdatabase.net, QUANTEL MEDICAL Aramis II for Sale - Bimedis, PDF 10(k) 023 7 37 - Food and Drug Administration

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Quantel Medical

Sources (1)

  • FDA 510(k) K032260 24 fields · synced Oct 1, 2026