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Chrys XX CO2 Surgical Laser System

by Jamar Medical Systems

510(k) K913606

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 NumberK913606 Date19 Dec 1991ClearedStatusActive

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  • Withdrawn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 Chrys XX CO2 Surgical Laser System is a surgical laser system designed for use in various medical procedures. It is intended for applications in gynecology, ENT, and dermatology, providing precise, low-bleeding, and tissue-sparing treatment.

The device is supplied by Jamar Medical Systems and has received FDA 510(k) clearance with product code GEX. It is designed for use in laser surgery procedures including incision, excision, vaporization, ablation, and other surgical applications. The system features indication-specific programs and various laser modes to support different surgical workflows.

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 Chrys XX CO2 Surgical Laser System used for?

    The Chrys XX CO2 Surgical Laser System is designed for various medical procedures including incision, excision, vaporization, and ablation in gynecology, ENT, and dermatology applications, providing precise treatment with minimal bleeding.

  • How is the Chrys XX CO2 Surgical Laser System supplied?

    The device is supplied by Jamar Medical Systems and includes indication-specific programs and various laser modes to support different surgical workflows in medical facilities.

  • What regulatory approval has the Chrys XX CO2 Surgical Laser System received?

    The Chrys XX CO2 Surgical Laser System has received FDA 510(k) clearance with product code GEX, classified as substantially equivalent to predicate devices in the general and plastic surgery category.

  • What are the key features of the Chrys XX CO2 Surgical Laser System?

    The system features indication-specific programs and various laser modes to support different surgical workflows, providing precise, low-bleeding, and tissue-sparing treatment for multiple medical specialties.