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Dlase 300 Upgrade

by Incirt Tech., Inc.

510(k) K932065

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 NumberK932065 Date22 Jul 1993ClearedStatusActive

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  • Withdrawn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, 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 Dlase 300 Upgrade is a medical device system designed for use in general and plastic surgery applications. It functions as an enhancement component for the Dlase 300 laser system.

This device is subject to FDA 510(k) clearance. It is identified under the product code GEX and was processed through a traditional clearance pathway.

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 primary purpose of the Dlase 300 Upgrade?

    The Dlase 300 Upgrade is specifically engineered to function as an enhancement component for the existing Dlase 300 laser system, supporting its use in general and plastic surgery applications.

  • What is the regulatory status of this device?

    The Dlase 300 Upgrade has received FDA 510(k) clearance. It was processed through a traditional clearance pathway and determined to be substantially equivalent to existing devices under product code GEX.

  • Which medical specialties is this upgrade intended for?

    This device is intended for use within the fields of general and plastic surgery, as indicated by the advisory committee classification associated with its regulatory filing.