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Eclipse 3200

by Cardiogenes 6 variants

510(k) K943311

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK943311 Date22 Jul 1994ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Eclipse 3200 is a carbon dioxide laser device designed for use in general surgery and dermatology. It functions by emitting light energy to cut, destroy, or remove tissue.

This device is classified as a Class 2 general and plastic surgery instrument. It has received FDA 510(k) clearance through the traditional pathway.

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Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Eclipse 3200?

    The Eclipse 3200 is a carbon dioxide laser device designed to emit light energy. This energy is utilized by clinicians to cut, destroy, or remove tissue during general surgery and dermatology procedures.

  • How is the Eclipse 3200 classified for regulatory purposes?

    The device is classified as a Class 2 general and plastic surgery instrument. It has received FDA 510(k) clearance through the traditional pathway, confirming it is substantially equivalent to legally marketed predicate devices.

  • What is the product code associated with this device?

    The Eclipse 3200 is categorized under product code GEX, which corresponds to the General and Plastic Surgery advisory committee classification for carbon dioxide laser systems.