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Diode laser system - Predator)

by Ivylaser (Beijing) Technology Co., Ltd

510(k) K250206

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 NumberK250206 Date24 Apr 2025ClearedStatusActive

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  • Withdrawn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
Models / Variants
Predator)
FDA applicant
Ivylaser (Beijing) Technology Co.,Ltd
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Diode laser system Night Universe Predator is a powered laser surgical instrument designed for hair removal. The device consists of a main unit containing the CPU, power supply, control and service panels, and a cooling system, along with a handlepiece and a foot switch.

This device is intended for operation by professionals in a clinical setting. It received FDA 510(k) clearance under K250206 on April 24, 2025.

Other devices from Ivylaser (Beijing) Technology Co., Ltd

Questions

AI-generated answers, 27 Sep 2026

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

  • What is the intended use of the Night Universe Predator?

    The Night Universe Predator is a powered laser surgical instrument specifically designed for hair removal procedures. It is intended for use by trained professionals within a clinical environment.

  • What components are included with the Night Universe Predator system?

    The system consists of a main unit that houses the CPU, power supply, control and service panels, and an integrated cooling system. Additionally, the device includes a handlepiece and a foot switch for operation.

  • What is the regulatory status of this laser system?

    The Night Universe Predator received FDA 510(k) clearance on April 24, 2025, under the submission number K250206. This indicates the device was found to be substantially equivalent to legally marketed predicate devices.