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Sharplan 723 CO2 Laser Surgical System

by Laser Industries, Ltd.

510(k) K801624

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 NumberK801624 Date20 Aug 1980ClearedStatusActive

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  • Withdrawn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
FDA applicant
Laser Industries , Ltd.
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 SHARPLAN 723 CO2 LASER SURGICAL SYSTEM is a medical device designed for surgical applications using a carbon dioxide laser. It is intended for use in procedures requiring precise tissue ablation and cutting, commonly in fields such as general surgery and plastic surgery.

The device is supplied as a single-use or reusable system, depending on the specific configuration, and must be stored in a controlled environment to maintain performance. It is regulated under FDA 510(k) clearance, with the advisory committee reviewing it for general and plastic surgery applications.

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Questions

AI-generated answers, 25 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 SHARPLAN 723 CO2 Laser Surgical System used for?

    The SHARPLAN 723 CO2 Laser Surgical System is designed for surgical applications that require precise tissue ablation and cutting. It is commonly used in fields such as general surgery and plastic surgery.

  • Is the SHARPLAN 723 CO2 Laser Surgical System intended for single use?

    The device is supplied as a single-use or reusable system, depending on the specific configuration. The intended use and configuration should be confirmed with the supplier.

  • How should the SHARPLAN 723 CO2 Laser Surgical System be stored?

    The device must be stored in a controlled environment to maintain its performance. Proper storage conditions are essential for ensuring the device functions as intended.

  • What is the regulatory status of the SHARPLAN 723 CO2 Laser Surgical System?

    The SHARPLAN 723 CO2 Laser Surgical System is regulated under FDA 510(k) clearance. The advisory committee reviewed it for applications in general and plastic surgery.