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Noblex Long Pulse Alexandrite Laser (K143666)

by FineMEC Co., Ltd

510(k) K143666Ref Noblex-00

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K143666↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809590140149 Basic UDI-DIDate20 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809590140149 UDI-DIDate27 May 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK143666 Date23 Apr 2015ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Full name
Noblex Long Pulse Alexandrite Laser
Trade Name
Noblex
Generic Name
Dermatological solid-state laser system
Model / Reference
Noblex-00 EUDAMED
Noblex GUDID
FDA applicant
Finemec Co., Ltd.
Primary DI / UDI-DI
08809590140149
Basic UDI-DI
B-08809590140149
510(k) Number
FDA Product Code
GEX
EMDN Code
Z120615 Therapeutic lasers
GMDN Term
Dermatological solid-state laser system
Device Class
Class IIb EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 878.4810
Market of Registration
Türkiye
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
Model / ReferenceEUDAMED
Noblex-00
510(k)
n/a
GUDID
Noblex
Device ClassEUDAMED
Class IIb
510(k)
Class II
GUDID
Class II

Overview

AI-generated summary, 18 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 Noblex Long Pulse Alexandrite Laser (K143666) is a laser device for hair removal (755 nm wavelength), designed to deliver controlled energy pulses for selective photothermolysis of hair follicles. It operates as a long-pulse alexandrite laser, targeting melanin in hair shafts to achieve long-term hair reduction with minimal epidermal damage.

This device is supplied as a non-sterile, reusable medical laser system for use in clinical settings by trained professionals. It requires proper handling, calibration, and maintenance as outlined in the manufacturer’s instructions. Authorised under FDA 510(k) clearance (K143666) and MDD compliance, it is classified under product code GEX for general and plastic surgery applications. Storage and operational conditions must adhere to regulatory and safety guidelines.

Other devices from FineMEC Co., Ltd

Questions

AI-generated answers, 18 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 clinical procedure is this laser primarily intended for, and how does it work?

    The Noblex Long Pulse Alexandrite Laser is designed specifically for hair removal, targeting melanin in hair follicles to achieve long-term reduction through selective photothermolysis. It emits a 755 nm wavelength and delivers controlled energy pulses to destroy hair follicles while minimizing damage to surrounding skin. This makes it suitable for professional use in clinical settings by trained practitioners.

  • Is this device single-use or reusable, and what maintenance is required?

    The Noblex Long Pulse Alexandrite Laser is a reusable medical device, not intended for single-use. Like all reusable lasers, it requires proper handling, calibration, and maintenance as specified in the manufacturer’s instructions to ensure safety and performance. Regular upkeep is essential to comply with regulatory guidelines and avoid operational risks.

  • How should this laser be stored, and are there any special conditions to consider?

    Storage must follow regulatory and safety guidelines to preserve functionality and compliance. While the device is non-sterile, it must be kept in a controlled environment to prevent contamination or damage. The manufacturer’s instructions outline specific conditions, including protection from extreme temperatures, humidity, and physical stress, to ensure proper operation.

  • What regulatory pathways has this device undergone, and how is it classified?

    The Noblex Long Pulse Alexandrite Laser has been authorized through FDA 510(k) clearance (K143666) and complies with the MDD (Medical Device Directive). It is classified under product code GEX, which falls under the General and Plastic Surgery category, indicating its intended use in professional clinical settings for cosmetic or surgical procedures.

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No