Medical Non-Ablative Fractional Laser Systems— 510(k) K192350

Name: FDA 510(k) clearance K192350
Creator: U.S. Food and Drug Administration
Published: 2020-04-30

Substantially Equivalent

Wingderm Electro-Optics , Ltd.

FDA 510(k) clearance K192350 for Medical Non-Ablative Fractional Laser Systems, Substantially Equivalent on 2020-04-30. Applicant: Wingderm Electro-Optics , Ltd.. Device class: 2.

Clearance details

Applicant: Wingderm Electro-Optics , Ltd.
Product code: Code ONG
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2019-08-29
Decision date: 2020-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

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Recalls naming K192350

K-number listed on FDA's recall record

Z-0555-2025 — Non-ablative Fractional Laser Systems, Model: WFB-01Class II·Ongoing·WINGDERM ELECTRO-OPTICS LTD.·20240823

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192350.

Data sourced from openFDA. This site is unofficial and independent of the FDA.