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FDA 510(k)

TRIOS SYSTEM

K-Number: K090399 · 2009-06-10

ApplicantViora , Ltd.
Decision Date2009-06-10
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRIOS 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 2009-06-10 under 510(k) number K090399. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIOS SYSTEM?

TRIOS SYSTEM is a medical device that received FDA 510(k) clearance on 2009-06-10. The listed applicant is Viora , Ltd.. The 510(k) number is K090399.

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

TRIOS SYSTEM received FDA 510(k) clearance on 2009-06-10, under 510(k) number K090399.

Who is the listed applicant for TRIOS 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 TRIOS SYSTEM?

The FDA product code for TRIOS SYSTEM is ONF.

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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 systemK090221REACTION SYSTEM

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Related Devices (Code: ONF)

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.

K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.K231952MEDILIGHTMedicreations, LLCK243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.K250281DEKA LOTUSEl.En S.P.A.K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T 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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