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Vectra Plus Laser System and Accessories

by Xintec Corporation 510(k)

Active United States

510(k) K082230

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK082230 Date3 Feb 2010ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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, 19 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 Vectra Plus Laser System is a diode laser device designed for dermatological and plastic surgery procedures. It emits wavelengths of 980 nm and 1470 nm, enabling precise tissue ablation, coagulation, and hair removal applications under controlled medical settings.

This system is supplied as a reusable medical device, cleared for use in general and plastic surgery environments. It is classified under Product Code GEX and was granted FDA 510(k) clearance as substantially equivalent to prior laser systems. The device requires proper training for operation and adheres to regulatory standards outlined in 21 CFR 878.4810.

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