FDA 510(k)

NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens

K-Nummer: K230910 · 2023-06-16

Entscheidungsdatum2023-06-16

ProduktcodeHQD

BeratungsausschussOP

EntscheidungSubstantially Equivalent

Produktübersicht

NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens is the device name listed in this FDA 510(k) record. The listed applicant is Acculens, Inc.. It received FDA 510(k) clearance on 2023-06-16 under 510(k) number K230910. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens?

NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens is a medical device that received FDA 510(k) clearance on 2023-06-16. The listed applicant is Acculens, Inc.. The 510(k) number is K230910.

When did NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens receive FDA 510(k) clearance?

NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens received FDA 510(k) clearance on 2023-06-16, under 510(k) number K230910.

Who is the listed applicant for NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens?

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

What is the FDA product code for NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens?

The FDA product code for NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens is HQD.

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

Verwandte Geräte (Code: HQD)

K253822GPA (hexafocon A) Rigid Gas Permeable Contact LensesZhuhai Fitlens Medical Technology Co., Ltd.K242393Acuity 181™ (tisilfocon A) und Acuity 181™ (tisilfocon A) mit Tangible™ Hydra-PEG® festen Gasdurchlässigen KontaktlinsenAcuity Polymers, Inc.K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd.K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A Bostonsight K240618Acuity 200™ (fluoroxyfocon A) fester Gasdurchlässiger Kontaktlinse; Acuity 100™ (hexafocon A) fester Gasdurchlässiger Kontaktlinse; Acuity 200™ mit Tangible® Hydra-PEG® (fluoroxyfocon A) fester Gasdurchlässiger Kontaktlinse; Acuity 100™ mit Tangible® Hydra-PEG® (hexafocon A) fester Gasdurchlässiger KontaktlinseAcuity Polymers, Inc.K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)Visionary Optics, 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.