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LAD (Epiture Easytouch), Model LAD-08

by Norwood Abbey, Ltd.

510(k) K033962

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 NumberK033962 Date20 Feb 2004ClearedStatusActive

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  • Withdrawn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
Norwood Abbey , 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, 26 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 device is a powered laser surgical instrument, as defined by its device type and classification. It is a portable, handheld, battery-powered laser surgical instrument that emits radiant energy at a wavelength of 2.94 µm with a 6 mm spot size at the treatment site.

It is supplied as a reusable device, cleared via FDA 510(k) under K033962 with product code GEX and classified as a Class II device. The clearance type is Special, and it was determined to be substantially equivalent. The device is intended for use in general and plastic surgery settings, as indicated by the advisory committee review.

Other devices from Norwood Abbey, Ltd.

Questions

AI-generated answers, 26 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 LAD (EPITURE EASYTOUCH), MODEL LAD-08 used for?

    The device is intended for use in general and plastic surgery settings, as indicated by the advisory committee review, and functions as a powered laser surgical instrument emitting radiant energy at a wavelength of 2.94 µm for tissue interaction during procedures.

  • How is the LAD (EPITURE EASYTOUCH), MODEL LAD-08 supplied and is it reusable?

    The device is supplied as a reusable, portable, handheld, battery-powered laser surgical instrument, meaning it is designed for multiple uses after appropriate cleaning and maintenance between procedures.

  • What are the key technical specifications of the LAD (EPITURE EASYTOUCH), MODEL LAD-08 laser?

    The device emits radiant energy at a wavelength of 2.94 µm with a 6 mm spot size at the treatment site, is battery-powered and handheld, and was cleared under FDA 510(k) K033962 with product code GEX as a Class II device.