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Navilas Laser System 577s

by OD-OS GmbH Germany EUDAMED510(k)GUDID

Ref 156000 Product code GEXEMDN Z12120202

Overview

The Navilas Laser System 577s is a Laser Device for Tissue Ablation (Nomenclature Code: Z12120202), designed for precise laser-based procedures in plastic and general surgery. It employs laser energy to selectively remove or reshape tissue, enabling controlled ablation for cosmetic or reconstructive applications, including skin resurfacing and scar revision.

This system is non-sterile, non-reusable, and non-implantable, supplied as a single-use device with a Basic UDI of 426028439NAVILASKZ. It is intended for use in clinical settings where laser-based tissue modification is required, with no known MRI compatibility restrictions. The device holds FDA 510(k) clearance under the Traditional pathway and is classified as Class IIb under MDR regulations. Storage and handling must adhere to manufacturer guidelines to ensure operational integrity.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number426028439NAVILASKZ Basic UDI-DIDate7 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260284390013 UDI-DIDate21 Nov 2023ListedStatusIn distribution
United StatesFDA 510(k) 510(k) NumberK162191 Date22 Nov 2016IssuedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Recalls: none on record (FDA, checked 25 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 25 Oct 2026

Generic Name
Fundus-imaging ophthalmic diode laser system
Device Name
Navilas
Model / Ref / Catalog
156000, Navilas® Laser System 577s
Primary DI / UDI-DI
04260284390013
Basic UDI-DI
426028439NAVILASKZ
FDA Product Code
GEX, HKI, NFF, NFG
EMDN Code
Z12120202 Laser photocoagulators
GMDN Term
Fundus-imaging ophthalmic diode laser system
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4810, 886.1120, 892.2010, 892.2020
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
156000
GUDID
Navilas® Laser System 577s
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000011735

Other devices from OD-OS GmbH

Questions

  • What types of surgical procedures is the Navilas Laser System 577s designed to assist with, and how does it achieve precision in those applications?

    The Navilas Laser System 577s is specifically designed for plastic and general surgery procedures involving laser-based tissue ablation. It enables precise removal or reshaping of tissue, making it suitable for applications like skin resurfacing and scar revision. The system achieves precision through controlled laser energy delivery, allowing clinicians to selectively modify tissue with minimal collateral damage, which is critical for cosmetic and reconstructive outcomes.

  • Is the Navilas Laser System 577s intended for single-use or repeated use in a clinical setting, and what does this mean for its maintenance and replacement?

    The Navilas Laser System 577s is explicitly designed as a single-use device, meaning it is not meant to be reused after a single procedure. This design choice eliminates the need for cleaning, sterilization, or maintenance between uses, reducing the risk of cross-contamination and ensuring consistent performance. Clinicians must replace the device after each use, adhering to the manufacturer’s guidelines to maintain operational integrity and patient safety.

  • How should the Navilas Laser System 577s be stored, and what considerations should be taken into account to ensure it remains functional?

    The Navilas Laser System 577s is non-sterile and must be stored according to the manufacturer’s instructions to preserve its functionality. Proper storage conditions—such as protecting it from physical damage, extreme temperatures, or moisture—are essential. Since it is a single-use device, storage should also account for shelf-life limitations, ensuring it is used within the specified timeframe to maintain performance and safety standards.

  • What regulatory pathways has the Navilas Laser System 577s followed, and how does this classification impact its use in clinical settings?

    The Navilas Laser System 577s has obtained FDA 510(k) clearance under the Traditional pathway, meaning it was determined to be substantially equivalent to a legally marketed predicate device. It is also classified as Class IIb under MDR regulations, indicating a moderate risk level requiring compliance with stringent manufacturing and performance standards. Clinicians can rely on this regulatory clearance to confirm the device’s safety and effectiveness for its intended laser-based tissue ablation procedures in plastic and general surgery.

  • Are there any known restrictions on using the Navilas Laser System 577s in environments with MRI machines, and what does this mean for its clinical application?

    The Navilas Laser System 577s has no known MRI compatibility restrictions listed in its documentation. This means it can generally be used in clinical settings where MRI machines are present without immediate concerns about interference or safety hazards. However, clinicians should always verify compatibility with their specific MRI protocols and facility guidelines to ensure safe coexistence in multi-modal environments.

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Serial Number
  • Manufacturing Date
Other properties (21)
  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (3)

  • EUDAMED dde0200c-fc49-42ed-a611-5bd4c0cba144 61 fields · synced 25 Oct 2026
  • FDA UDI fcfbe706-3c70-4e6a-8cb7-62b948ed8f4b 36 fields · synced 30 May 2026
  • FDA 510(k) K141851 1 fields · synced 18 May 2026