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FDA 510(k)

SR-1 Skin Treatment System

K-Number: K221268 · 2022-11-21

ApplicantAVAVA, Inc.
Decision Date2022-11-21
Product CodeONG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SR-1 Skin Treatment System is a medical device manufactured by AVAVA, Inc.. It received FDA 510(k) clearance on 2022-11-21 under approval number K221268. 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 SR-1 Skin Treatment System?

SR-1 Skin Treatment System is a medical device that received FDA 510(k) clearance on 2022-11-21. It is manufactured by AVAVA, Inc.. The 510(k) number is K221268.

When was SR-1 Skin Treatment System approved by the FDA?

SR-1 Skin Treatment System received FDA 510(k) clearance on 2022-11-21, under approval number K221268.

What company makes SR-1 Skin Treatment System?

SR-1 Skin Treatment System is manufactured by AVAVA, Inc..

What is the FDA product code for SR-1 Skin Treatment System?

The FDA product code for SR-1 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 K213726PL-1 Skin Treatment System K223871Miria 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. K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.

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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