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Facilai Various Models Of Single Use Acupuncture Needle

by Facilai Enterprises, Ltd.

510(k) K031818

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 NumberK031818 Date3 Dec 2003ClearedStatusActive

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  • Withdrawn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
MQX
FDA applicant
Facilai Enterprises , Ltd.
Device Class
Class II
Regulation
21 CFR Part 880.5580
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Facilai Various Models of Single Use Acupuncture Needle is a device intended for skin penetration during acupuncture therapy. It is designed to facilitate traditional acupuncture procedures and contains no electronic, mechanical, or software components.

This single-use device is intended for operation by qualified practitioners in clinical settings. It is regulated under 21 CFR 880.5580 and has received FDA 510(k) clearance under K031818.