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Laser Fiber - Laser Fiber (PT-OF-E-S)

by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

510(k) K253007Ref /Model PT-OF-A, PT-OF-B, PT-OF-C, PT-OF-D, PT-OF-E, PT-OF-F

Active European Union and United States

CE MDR 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) K253007↗

FDA record

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697320421PT-OF-XKH Basic UDI-DI Date12 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK253007 Date20 Nov 2025ClearedStatusActive

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  • Withdrawn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/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Model / Reference
PT-OF-A, PT-OF-B, PT-OF-C, PT-OF-D, PT-OF-E, PT-OF-F, /
Primary DI / UDI-DI
06973204212132, 06973204212156, 06973204212095, 06973204212187, 06973204212088, 06973204212170
Basic UDI-DI
697320421PT-OF-XKH
Direct Marketing DI
06973204212132
06973204212156
06973204212095
06973204212187
06973204212088
06973204212170
510(k) Number
FDA Product Code
GEX
EMDN Code
Z12011080 Laser surgery instruments - hardware accessories
Models / Variants
Laser Fiber (PT-OF-E-S)
Device Class
Class IIa EUDAMED
Class II 510(k)
Regulation
21 CFR Part 878.4810
EU market of registration
Germany
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class IIa
510(k)
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 Laser Fiber (PT-OF-A-S) through (PT-OF-F-S) is a delivery device classified as a Laser Fiber under the General, Plastic Surgery advisory committee category. These fibers are designed to transmit laser energy from a source to target tissue during surgical procedures, compatible with lasers operating within the wavelength range of 1940nm to 2100nm and equipped with an SMA 905 standard connector.

These fibers are supplied as reusable medical devices and are intended for use in controlled surgical environments. They are not sterile at time of shipment and must be sterilized prior to use, adhering to standard medical device sterilization protocols. Each model is authorized under FDA 510K and MDR compliance, with the specific product code GEX assigned for regulatory tracking. Proper handling, storage, and sterilization procedures must be followed to ensure safety and functionality.

Other devices from Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

See all devices from Guangzhou Potent Medical Equipment Joint-Stock 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.

  • Are these laser fibers intended for single-use or can they be reused after sterilization?

    These laser fibers are designed as reusable medical devices. They must be sterilized prior to each use following standard medical device sterilization protocols to ensure safety and functionality. The manufacturer emphasizes proper handling and sterilization procedures to maintain performance.

  • What types of lasers are these fibers compatible with, and how are they connected?

    These fibers are designed to transmit laser energy for surgical procedures and are compatible with lasers operating within the wavelength range of 1940nm to 2100nm. They feature an SMA 905 standard connector, ensuring compatibility with laser systems that use this interface.

  • Are these fibers sterile when shipped, and what regulatory compliance do they hold?

    No, these fibers are not sterile at the time of shipment and must be sterilized before use. They are authorized under both FDA 510K and MDR compliance, with the product code GEX assigned for regulatory tracking.

  • What should I consider when storing these laser fibers to maintain their integrity?

    Since these fibers are reusable and require sterilization, proper storage involves keeping them in a clean, dry environment away from direct sunlight or extreme temperatures. Follow manufacturer guidelines for storage to prevent damage and ensure they remain functional for repeated sterilization cycles.

  • How do I know which model of laser fiber is right for my surgical application?

    The fibers are differentiated by model (PT-OF-A-S through PT-OF-F-S), but the manufacturer does not specify functional differences between them in the provided data. Ensure your laser system operates within the 1940nm–2100nm wavelength range and uses an SMA 905 connector—all models support these requirements. Confirm compatibility with your specific laser device before purchase.

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No