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FDA 510(k)

Medical Non-Ablative Fractional Laser Systems

K-Number: K192350 · 2020-04-30

ApplicantWingderm Electro-Optics , Ltd.
Decision Date2020-04-30
Product CodeONG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical Non-Ablative Fractional Laser Systems is a medical device manufactured by Wingderm Electro-Optics , Ltd.. It received FDA 510(k) clearance on 2020-04-30 under approval number K192350. The device is classified under product code ONG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medical Non-Ablative Fractional Laser Systems?

Medical Non-Ablative Fractional Laser Systems is a medical device that received FDA 510(k) clearance on 2020-04-30. It is manufactured by Wingderm Electro-Optics , Ltd.. The 510(k) number is K192350.

When was Medical Non-Ablative Fractional Laser Systems approved by the FDA?

Medical Non-Ablative Fractional Laser Systems received FDA 510(k) clearance on 2020-04-30, under approval number K192350.

What company makes Medical Non-Ablative Fractional Laser Systems?

Medical Non-Ablative Fractional Laser Systems is manufactured by Wingderm Electro-Optics , Ltd..

What is the FDA product code for Medical Non-Ablative Fractional Laser Systems?

The FDA product code for Medical Non-Ablative Fractional Laser Systems is ONG.

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K191611Diode Laser Therapy Systems K252599Diode Laser Therapy Systems (WLA-02)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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