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LS-40 CO2 Laser System Model LS-40

by Sandstone Medical Technologies, LLC

510(k) K093793

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 · Special NumberK093793 Date18 Feb 2010ClearedStatusActive

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  • Withdrawn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, 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 LS-40 CO2 Laser System Model LS-40 is a laser device intended for coagulation, vaporization, ablation, or cutting of soft tissue in dermatology and plastic surgery, general surgery, and podiatry. It is substantially equivalent to a predicate device and received FDA 510(k) clearance under product code GEX.

The system is supplied as a complete laser unit and is intended for use in clinical settings such as dermatology, plastic surgery, general surgery, and podiatry. It is authorized for marketing in the United States under FDA 510(k) clearance K093793, with no indication of sterility, single-use status, MRI safety, or specific storage requirements provided in the data.

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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 LS-40 CO2 Laser System Model LS-40 used for?

    The LS-40 CO2 Laser System Model LS-40 is intended for coagulation, vaporization, ablation, or cutting of soft tissue in dermatology, plastic surgery, general surgery, and podiatry, based on its FDA 510(k) clearance as substantially equivalent to a predicate device under product code GEX.

  • How is the LS-40 CO2 Laser System Model LS-40 supplied and intended for use?

    The system is supplied as a complete laser unit and is intended for use in clinical settings such as dermatology, plastic surgery, general surgery, and podiatry, with no indication of sterility, single-use status, or specific storage requirements provided in the authorization data.

  • Does the LS-40 CO2 Laser System Model LS-40 have any sterility or single-use specifications?

    The device data does not provide any indication of sterility, single-use status, or reprocessing requirements for the LS-40 CO2 Laser System Model LS-40, so such specifications cannot be confirmed from the available information.