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FDA 510(k)

DUO

K-Number: K161565 · 2016-09-01

ApplicantStetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd
Decision Date2016-09-01
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DUO is the device name listed in this FDA 510(k) record. The listed applicant is Stetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd. It received FDA 510(k) clearance on 2016-09-01 under 510(k) number K161565. 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 DUO?

DUO is a medical device that received FDA 510(k) clearance on 2016-09-01. The listed applicant is Stetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd. The 510(k) number is K161565.

When did DUO receive FDA 510(k) clearance?

DUO received FDA 510(k) clearance on 2016-09-01, under 510(k) number K161565.

Who is the listed applicant for DUO?

The FDA 510(k) record lists Stetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUO?

The FDA product code for DUO is ONF.

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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