FDA 510(k)

LED-Lichttherapie-Face-Maske (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)

K-Nummer: K253400 · 2025-12-24

AntragstellerShenzhen Saidi Light Therapy Technology Co., Ltd.

Entscheidungsdatum2025-12-24

ProduktcodeOHS

BeratungsausschussSU I'm sorry, but it seems like the text you provided is incomplete. Could you please provide the full description or text that you would like translated into German?

EntscheidungSubstantiell Äquivalent

Produktübersicht

LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Saidi Light Therapy Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-12-24 under 510(k) number K253400. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)?

LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) is a medical device that received FDA 510(k) clearance on 2025-12-24. The listed applicant is Shenzhen Saidi Light Therapy Technology Co., Ltd.. The 510(k) number is K253400.

When did LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) receive FDA 510(k) clearance?

LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) received FDA 510(k) clearance on 2025-12-24, under 510(k) number K253400.

Who is the listed applicant for LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)?

The FDA 510(k) record lists Shenzhen Saidi Light Therapy Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)?

The FDA product code for LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) is OHS.

Zugehörige klinische Studien

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

NCT07608549FLASH Pilot Phase 1 SicherheitstudieNOT_YET_RECRUITING NCT06562205PAP-Systeme Externe Klinische Studien (ECS)NOT_YET_RECRUITING NCT06443177Der Einfluss der Sympathikmodulation auf den zerebralen Vasospasmus sekundär zu einem aneurysmalen SubarachnoidblutungSUSPENDED NCT07095751Künstlich-intelligenz-assistiertes Uro-Cam Katheter-Assessment-System zur Diagnose von BlasenkrebsNOT_YET_RECRUITING

Verwandte Geräte (Code: OHS)

K260767Gesichtschönheitsgerät (Gesichtsmasken-LED-Schönheitsgerät A-901; Gesicht LED & EMS-Schönheitsgerät A-902; Gesichtsmasken-LED & EMS-Schönheitsgerät A-907)Kam Yuen Plastic Products , Ltd.K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.K261601LED-Lichttherapie-Maske (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.K261496LED-Lichttherapie-Masken (PE748, PE749, PE756)Duplex International Trading Limited K261851LED-Lichttherapie-Maske (JML1, JML1+JML2); LED-Lichttherapie-Maske (JML3, JML3+JML4); LED-Lichttherapie-Maske (JML5, JML5+JML7); LED-Lichttherapie-Maske (JML6, JML6+JML8); LED-Lichttherapie-Maske (JML9, JML9+JML10)Shenzhen Qianyu Technology Co., Ltd.K261482LightStim für Falten (1984); LightStim für Akne (2038)Led Intellectual Properties, LLC

Offizielle Quelle

In der FDA-Datenbank anzeigen →

Daten aus der FDA Open API. Für die aktuellsten und verbindlichen Informationen konsultieren Sie bitte stets den offiziellen Datensatz.