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FDA 510(k)

REACTION SYSTEM

K-Number: K090221 · 2009-07-01

ApplicantViora , Ltd.
Decision Date2009-07-01
Product CodeNUV
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REACTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Viora , Ltd.. It received FDA 510(k) clearance on 2009-07-01 under 510(k) number K090221. The device is classified under product code NUV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REACTION SYSTEM?

REACTION SYSTEM is a medical device that received FDA 510(k) clearance on 2009-07-01. The listed applicant is Viora , Ltd.. The 510(k) number is K090221.

When did REACTION SYSTEM receive FDA 510(k) clearance?

REACTION SYSTEM received FDA 510(k) clearance on 2009-07-01, under 510(k) number K090221.

Who is the listed applicant for REACTION SYSTEM?

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

What is the FDA product code for REACTION SYSTEM?

The FDA product code for REACTION SYSTEM is NUV.

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Other records listing Viora , Ltd. 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.

K202247V30 system, V20 system, V10 system, V-VR Hand pieceK201064V30 System, V20 System, V10 System, V-FR HandpieceK200468V30 system, V20 system, V10 system, V-FC HandpieceK162363V30 system, V-Form Handpiece BC Medium applicatorK152611V20 systemK090399TRIOS SYSTEM

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Related Devices (Code: NUV)

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.

K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K231092T-SHAPE 2B&M S.R.L. Marketing Nel BenessereK211272ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries SrlK182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)I-Tech Industries SrlK161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd.K131362INMODE WMBODY DEVICEInmode MD , 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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