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Lyra Acupuncture Needles

by Helio Medical Supplies, Inc.

510(k) K062448

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 NumberK062448 Date20 Sep 2006ClearedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 880.5580
Advisory Committee
General Hospital
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 Lyra Acupuncture Needles are sterile, single-use acupuncture needles designed for skin penetration during acupuncture therapy. Classified as a Needle, Acupuncture device, they are intended for use by qualified practitioners to stimulate specific acupuncture points on the body.

These needles are supplied in a color-coded dispenser for gauge identification, with each dispenser containing 10 needles plus 2 guide tubes. They are packaged in 30 pouches per box, totaling 300 needles, and are regulated under FDA 510(k) clearance (K062448). The devices are non-reusable and intended for single-use only, adhering to medical device standards for sterility and safety.

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See all devices from Helio Medical Supplies, Inc. →

Questions

AI-generated answers, 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.

  • Are the Lyra Acupuncture Needles reusable or intended for single-use only?

    The Lyra Acupuncture Needles are explicitly designed for single-use only. This aligns with medical device standards for sterility and safety, ensuring each needle remains uncontaminated for one procedure. Reuse is not recommended or supported by the manufacturer.

  • How are the Lyra Acupuncture Needles packaged and supplied for clinical use?

    The needles come in color-coded dispensers, each containing 10 needles plus 2 guide tubes. These dispensers are grouped into 30 pouches per box, totaling 300 needles per box. This packaging helps practitioners quickly identify gauge sizes and maintain sterility before use.

  • What regulatory pathway does the Lyra Acupuncture Needle follow, and how does it ensure compliance?

    The Lyra Acupuncture Needles are regulated under the FDA 510(k) clearance process, with the specific clearance number K062448. This pathway confirms the device is substantially equivalent to a legally marketed predicate, ensuring compliance with U.S. medical device regulations before commercial distribution.

  • How many needles are included in a single box, and what is the practical use case for this quantity?

    Each box contains 300 needles, organized into 30 pouches of 10 needles each. This quantity is ideal for clinics or practitioners treating multiple patients daily, as it balances convenience with inventory management while maintaining sterility through individual pouch sealing.