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FDA 510(k)

ENEO TOTALE (Model: ENEOT947)

K-Number: K213841 · 2022-01-06

ApplicantPremier North America, Inc.
Decision Date2022-01-06
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENEO TOTALE (Model: ENEOT947) is the device name listed in this FDA 510(k) record. The listed applicant is Premier North America, Inc.. It received FDA 510(k) clearance on 2022-01-06 under 510(k) number K213841. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENEO TOTALE (Model: ENEOT947)?

ENEO TOTALE (Model: ENEOT947) is a medical device that received FDA 510(k) clearance on 2022-01-06. The listed applicant is Premier North America, Inc.. The 510(k) number is K213841.

When did ENEO TOTALE (Model: ENEOT947) receive FDA 510(k) clearance?

ENEO TOTALE (Model: ENEOT947) received FDA 510(k) clearance on 2022-01-06, under 510(k) number K213841.

Who is the listed applicant for ENEO TOTALE (Model: ENEOT947)?

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

What is the FDA product code for ENEO TOTALE (Model: ENEOT947)?

The FDA product code for ENEO TOTALE (Model: ENEOT947) is OHS.

Other records listing Premier North America, 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.

K233862NUNA LUX (NUNL528)K232656BLU TOTALE (Model: ENEOB852)K220735Avologi Gel Primer (Model: Av25)K214100LuminiceK181659Avologi ENEO

Related Devices (Code: OHS)

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.

K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)Shenzhen Qianyu Technology Co., Ltd.K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading LimitedK261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLCK2605985 Wavelength LED Facemask (TN2508)iSMART Developments, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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