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FDA 510(k)

Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine

Numéro K : K200983 · 2021-07-14

DemandeurNingbo Hesi Electric Co., Ltd.
Date de décision2021-07-14
Code produitOHS
Comité consultatifSU
DécisionSubstantially Equivalent

Résumé du dispositif

Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Hesi Electric Co., Ltd.. It received FDA 510(k) clearance on 2021-07-14 under 510(k) number K200983. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine?

Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine is a medical device that received FDA 510(k) clearance on 2021-07-14. The listed applicant is Ningbo Hesi Electric Co., Ltd.. The 510(k) number is K200983.

When did Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine receive FDA 510(k) clearance?

Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine received FDA 510(k) clearance on 2021-07-14, under 510(k) number K200983.

Who is the listed applicant for Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine?

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

What is the FDA product code for Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine?

The FDA product code for Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine is OHS.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Dispositifs connexes (Code : OHS)

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)Kam Yuen Plastic Products , Ltd.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, LLC

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