FDA 510(k)

AVAVA Skin Treatment System

K-Number: K252155 · 2025-10-20

Decision Date2025-10-20

Product CodeONG

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AVAVA Skin Treatment System is a medical device manufactured by AVAVA, Inc.. It received FDA 510(k) clearance on 2025-10-20 under approval number K252155. 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 AVAVA Skin Treatment System?

AVAVA Skin Treatment System is a medical device that received FDA 510(k) clearance on 2025-10-20. It is manufactured by AVAVA, Inc.. The 510(k) number is K252155.

When was AVAVA Skin Treatment System approved by the FDA?

AVAVA Skin Treatment System received FDA 510(k) clearance on 2025-10-20, under approval number K252155.

What company makes AVAVA Skin Treatment System?

AVAVA Skin Treatment System is manufactured by AVAVA, Inc..

What is the FDA product code for AVAVA Skin Treatment System?

The FDA product code for AVAVA Skin Treatment System is ONG.

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Other Devices by AVAVA, Inc.

K202884SR-1 Skin Treatment System K221268SR-1 Skin Treatment System K213726PL-1 Skin Treatment System K223871Miria Skin Treatment System K250402AVAVA Skin Treatment System

Related Devices (Code: ONG)

K162398CO2 Laser Therapy SystemsBeijing Sincoheren Science and Technology Development Co. K182498Advanced Skin Renewing DeviceJiangsu Unimed Laser Technology Co., Ltd. K180036SMAXEL CO2 Surgical Laser SystemIds, Ltd. K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics , Ltd. K202884SR-1 Skin Treatment SystemAVAVA, Inc. K221268SR-1 Skin Treatment SystemAVAVA, Inc.

Official Source

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