Medical Non-Ablative Fractional Laser Systems

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K192350

Identifiers

510(k) Number: K192350 FDA 510(k)
FDA Product Code: ONG FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 878.4810 FDA 510(k)
Regulation Number: 878.4810 FDA 510(k)
Advisory Committee: General, Plastic Surgery FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Medical Non-Ablative Fractional Laser Systems are powered laser devices designed for fractional skin resurfacing and soft tissue coagulation. These systems deliver precise, non-ablative laser energy to stimulate collagen remodeling and improve skin texture without removing the epidermis, making them suitable for dermatological treatments such as acne scars and striae.

Used in clinical settings for dermatological procedures, these systems are supplied as reusable medical devices with FDA 510(k) clearance and MDR compliance. They operate at a 1550 nm wavelength, enabling deep dermal penetration for thermal coagulation while minimizing surface damage. Multiple model references are listed under regulatory filings, and their use adheres to standard laser safety protocols.

This description and any FAQs above were generated automatically from registry data 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. Sources consulted: Renuva - Wingderm Electro-Optics Ltd., PDF Wingderm Electro-Optics Ltd. - Food and Drug Administration, Medical Non-Ablative Fractional Laser Systems, Wingderm Secures MDR Certification for Non-Ablative Fractional Laser System

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K192350	Class II	Active

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Manufacturer

Manufacturer: Wingderm Electro-Optics Ltd.
FDA Applicant: Wingderm Electro-Optics , Ltd.

Sources (2)

FDA 510(k) K192350 24 fields · synced Sep 20, 2026
EUDAMED 1 fields · synced May 18, 2026