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Hexascan Handpiece

by Lihtan Technologies, Inc.

510(k) K901008

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 NumberK901008 Date3 May 1990ClearedStatusActive

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  • Withdrawn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, 20 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 Hexascan Handpiece is a powered laser surgical instrument designed for use with argon and dye lasers. It delivers focused laser energy to perform precise tissue ablation, coagulation, or vaporisation in surgical procedures, particularly within general and plastic surgery applications. The device is engineered to interface with laser systems, enabling controlled energy delivery for clinical interventions.

This handpiece is supplied as a reusable medical device, intended for use in sterile surgical environments. It is classified under FDA product code GEX and has received a 510(k) clearance (K901008) for substantial equivalence. The device is regulated under the classification name Powered Laser Surgical Instrument, adhering to FDA standards for laser-based surgical tools. No specific MRI safety or single-use indications are stated in the regulatory data.

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