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Lasya-Trinity

by BLUECORE COMPANY Co., Ltd.

510(k) K241951

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 NumberK241951 Date10 Oct 2024ClearedStatusActive

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  • Withdrawn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, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Lasya Trinity is a Korean three-wavelength diode laser device operating at 755nm, 808nm, and 1064nm simultaneously. It is designed to effectively target various depths within the skin for hair removal applications.

The device is supplied as a single-use medical laser system. It is intended for use by trained healthcare professionals in clinical settings. The device is not sterilized and requires aseptic handling before use.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What wavelengths does the Lasya-Trinity laser operate at?

    The Lasya-Trinity is a three-wavelength diode laser that operates at 755nm, 808nm, and 1064nm simultaneously.

  • Is the Lasya-Trinity device sterile?

    No, the device is not sterilized and requires aseptic handling before use.

  • How is the Lasya-Trinity laser system supplied?

    The device is supplied as a single-use medical laser system intended for use by trained healthcare professionals in clinical settings.

  • What is the primary application of the Lasya-Trinity?

    The device is designed to effectively target various depths within the skin for hair removal applications.