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Crystal Vision

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K163659

by I.C. Medical, Inc.

Identifiers

510(k) Number
K163659 FDA 510(k)
FDA Product Code
FYD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.5070 FDA 510(k)
Regulation Number
878.5070 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Crystal Vision Surgical Smoke Evacuation System is a Class II surgical exhaust apparatus designed to remove smoke, plume, and particulate generated during electrosurgical procedures. It interfaces with various cutting devices, including harmonic scalpel and monopolar/bipolar electrosurgical tools, to enhance operating room air quality and reduce exposure to surgical staff.

This device is supplied as a reusable system, featuring a ULPA filter that requires periodic replacement when its capture efficiency falls below 100%. It operates in standard surgical environments and is regulated under FDA 510(k) clearance (K163659) and EU MDR compliance. Multiple filter reference codes (e.g., 3011763071, 1000268645) are available to accommodate different procedural volumes and surgical specialties, including general and plastic surgery.

Frequently asked questions

How does the Crystal Vision Surgical Smoke Evacuation System improve air quality in the operating room during electrosurgical procedures?

The Crystal Vision system actively removes smoke, plume, and particulate generated during electrosurgical procedures—such as those involving harmonic scalpels or monopolar/bipolar tools—by interfacing directly with these devices. This reduces airborne contaminants, enhancing OR air quality and minimizing exposure for surgical staff.

Is the Crystal Vision system reusable, and if so, what components require replacement?

Yes, the Crystal Vision system is designed for reuse. The key consumable component is the ULPA filter, which must be periodically replaced when its capture efficiency drops below 100%. Multiple filter reference codes are available to match procedural volumes and specialties like general or plastic surgery.

What surgical specialties is the Crystal Vision system approved for, and how does that affect filter selection?

The system is approved for use in general and plastic surgery, as well as other procedures generating surgical smoke. Filter selection is tailored to procedural volume and specialty needs, with various reference codes (e.g., 3011763071, 1000268645) ensuring compatibility with different workflows.

How is the Crystal Vision system regulated, and what does its FDA clearance status entail?

The Crystal Vision Surgical Smoke Evacuation System holds FDA 510(k) clearance (K163659) under the Special 510(k) pathway, classified as a Class II device. This clearance confirms it is *substantially equivalent* to a legally marketed predicate device, ensuring compliance with U.S. safety and performance standards for surgical exhaust apparatuses.

Are there specific storage requirements for the reusable components of the Crystal Vision system?

While the device data does not specify storage conditions, reusable components like the housing and tubing should be stored in a clean, dry environment to prevent contamination. The ULPA filters (when not in use) should be kept in sealed packaging until replacement to maintain sterility and functionality.

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: Crystal Vision® - Surgical Smoke Evacuation Systems - IC Medical ..., crystalvision - IC Medical - Global Leaders in Surgical Smoke ..., crystalVision - IC Medical - Global Leaders in Surgical Smoke ..., Product Catalog - IC Medical - Global Leaders in Surgical Smoke ..., Crystal Vision - Surgical Smoke Evacuation Systems

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
I.C. Medical, Inc.
FDA Applicant
I.C Medical, Inc.

Sources (2)

  • FDA 510(k) K163659 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 19, 2026