Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is AVAVA, Inc.. It received FDA 510(k) clearance on 2023-06-22 under 510(k) 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. The listed applicant is AVAVA, Inc.. The 510(k) number is K223871.

When did Miria Skin Treatment System receive FDA 510(k) clearance?

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

Who is the listed applicant for Miria 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 Miria Skin Treatment System?

The FDA product code for Miria 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 SystemK221268SR-1 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 AestheticK221268SR-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.

↑