MX-7000 Microxel

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K111831 ↗

FDA Product Code

ONG

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• What types of procedures is the MX-7000 Microxel primarily used for in clinical settings?

  The MX-7000 Microxel is designed for precise tissue ablation and resurfacing, making it suitable for procedures in general and plastic surgery. Its fractional laser output minimizes collateral damage, which is particularly useful for skin and soft tissue treatments, such as resurfacing, scar revision, or other laser-based dermatological or reconstructive applications.

• Is the MX-7000 Microxel a single-use or reusable device, and how should it be maintained?

  The MX-7000 Microxel is a reusable surgical instrument, intended for use in clinical settings where laser-based treatments are performed. Since it is reusable, it must be cleaned, disinfected, and sterilized according to standard sterile surgical instrument protocols to ensure safety and functionality between uses.

• Can the MX-7000 Microxel be used in MRI environments, and what are the storage requirements?

  The MX-7000 Microxel is designed with MRI compatibility in mind where applicable, meaning it can be safely used in MRI environments if the specific model and settings allow it. Storage should follow standard sterile surgical instrument protocols, ensuring it remains clean, dry, and protected from contamination until use.

• What regulatory pathway was followed for FDA clearance of the MX-7000 Microxel, and what does this mean for its use?

  The MX-7000 Microxel received FDA 510(k) clearance (K111831) under a Traditional 510(k) review, meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance allows it to be legally marketed and used in clinical settings for its intended purposes, which include fractional laser tissue ablation and resurfacing in general and plastic surgery.