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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 the device name listed in this FDA 510(k) record. The listed applicant is AVAVA, Inc.. It received FDA 510(k) clearance on 2022-11-21 under 510(k) 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. The listed applicant is AVAVA, Inc.. The 510(k) number is K221268.

When did SR-1 Skin Treatment System receive FDA 510(k) clearance?

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

Who is the listed applicant for SR-1 Skin Treatment System?

The FDA 510(k) record lists AVAVA, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for SR-1 Skin Treatment System is ONG.

Other records listing AVAVA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252155AVAVA™ Skin Treatment SystemK250402AVAVA™ Skin Treatment SystemK223871Miria Skin Treatment SystemK213726PL-1 Skin Treatment SystemK202884SR-1 Skin Treatment System

Related Devices (Code: ONG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.K244060eCO2 3DLutronic CorporationK251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.K233550MOSAIC 3D (Surgical Laser)Lutronic AestheticK223871Miria 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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