FDA 510(k)

Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)

K-Nummer: K242595 · 2024-11-07

AntragstellerShenzhen Greatro Electronic Technology Co., Ltd.

Entscheidungsdatum2024-11-07

ProduktcodeOHT

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Greatro Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-11-07 under 510(k) number K242595. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)?

Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) is a medical device that received FDA 510(k) clearance on 2024-11-07. The listed applicant is Shenzhen Greatro Electronic Technology Co., Ltd.. The 510(k) number is K242595.

When did Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) receive FDA 510(k) clearance?

Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) received FDA 510(k) clearance on 2024-11-07, under 510(k) number K242595.

Who is the listed applicant for Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)?

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

What is the FDA product code for Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)?

The FDA product code for Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) is OHT.

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 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Weitere Einträge mit Shenzhen Greatro Electronic Technology Co., Ltd. als Antragsteller

K232932Intense Pulse Light Therapeutic Apparatus

Verwandte Geräte (Code: OHT)

K261977Braun Aura 9 (6042)Cyden Limited K262524Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)ONE BEAUTY Technology Co., Ltd.K261705Hair Removal Device (R3C16-G Pro, R3C16-V Pro)Shenzhen Jianchao Intelligent Technology Co., Ltd.K261325Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)Shenzhen Ulike Smart Electronics Co., Ltd.K260594IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)Shenzhen Xiazhifeng Electronic Co., Ltd.K260742Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)Shenzhen Ulike Smart Electronics Co., Ltd.

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.