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Tru-Pulse Pulsed CO2 Surgical Laser System

by Tissue Technologies, Inc.

510(k) K952049

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 NumberK952049 Date21 Jul 1995ClearedStatusActive

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  • Withdrawn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, 1 Oct 2026

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

The Tru-Pulse Pulsed CO₂ Surgical Laser System is a pulsed carbon dioxide (CO₂) laser designed for surgical procedures. It operates using RF-excited gas-slab technology to deliver precise, controlled energy for soft tissue manipulation, including coagulation, vaporization, ablation, and cutting. The device is classified under the product code GEX, aligning with general surgical laser applications.

This system is intended for use in clinical settings by physicians, providing adjustable power output ranging from 1 to 10 watts of average power. It is a reusable device, supplied sterile or non-sterile as required for surgical environments, with no specific MRI safety restrictions noted. The system holds an FDA 510(k) clearance (K952049) under the Traditional pathway, with a decision date of July 21, 1995, and is regulated under the Substantially Equivalent (SESE) classification for general and plastic surgery applications.

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Questions

AI-generated answers, 1 Oct 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 Tru-Pulse Pulsed CO₂ Surgical Laser System used for?

    The Tru-Pulse Pulsed CO₂ Surgical Laser System is designed for soft tissue surgical procedures, including coagulation, vaporization, ablation, and cutting. Its RF-excited gas-slab technology enables precise energy delivery, making it suitable for clinical settings where controlled tissue manipulation is required. The adjustable power output (1–10 watts) allows physicians to tailor settings to specific surgical needs.

  • Is the Tru-Pulse Pulsed CO₂ Surgical Laser System reusable or single-use?

    The Tru-Pulse Pulsed CO₂ Surgical Laser System is a reusable device. It can be supplied either sterile or non-sterile depending on the surgical environment’s requirements, ensuring flexibility for clinical use.

  • What power settings does the Tru-Pulse Pulsed CO₂ Surgical Laser System offer?

    The system provides adjustable power output ranging from 1 to 10 watts of average power. This range allows surgeons to select the appropriate energy level for tasks such as cutting, coagulation, or vaporization, enhancing precision during procedures.

  • Does the Tru-Pulse Pulsed CO₂ Surgical Laser System have any MRI safety restrictions?

    No specific MRI safety restrictions are noted for the Tru-Pulse Pulsed CO₂ Surgical Laser System. However, standard MRI safety protocols should still be followed when using or storing the device in proximity to MRI environments.

  • What regulatory pathway and clearance does the Tru-Pulse Pulsed CO₂ Surgical Laser System hold?

    The Tru-Pulse Pulsed CO₂ Surgical Laser System holds an FDA 510(k) clearance (K952049) under the Traditional pathway, classified as Substantially Equivalent (SESE) for general and plastic surgery applications. The clearance was granted on July 21, 1995, following review by the Surgical Devices Panel (SU).