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FDA 510(k)

Miria Skin Treatment System

K-Number: K223871 · 2023-06-22

ApplicantAVAVA, Inc.
Decision Date2023-06-22
Product CodeONG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Miria Skin Treatment System is a medical device manufactured by AVAVA, Inc.. It received FDA 510(k) clearance on 2023-06-22 under approval number K223871. 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 Miria Skin Treatment System?

Miria Skin Treatment System is a medical device that received FDA 510(k) clearance on 2023-06-22. It is manufactured by AVAVA, Inc.. The 510(k) number is K223871.

When was Miria Skin Treatment System approved by the FDA?

Miria Skin Treatment System received FDA 510(k) clearance on 2023-06-22, under approval number K223871.

What company makes Miria Skin Treatment System?

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

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

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

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Related PubMed Literature

PMID: 41251011 Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series. International wound journal (2025) PMID: 40258332 Chronic expanding hematoma following Gamma Knife irradiation for primary central nervous system lymphoma: illustrative case. Journal of neurosurgery. Case lessons (2025)

Other Devices by AVAVA, Inc.

K202884SR-1 Skin Treatment System K221268SR-1 Skin Treatment System K213726PL-1 Skin Treatment System K252155AVAVA™ 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

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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