FDA 510(k)

Lunettes de contact souples Alcon (serafilcon A) pour usage quotidien

Numéro K : K212806 · 2021-12-28

Date de décision2021-12-28

Code produitLPL

Comité consultatifOP

DécisionSubstantially Equivalent

Résumé du dispositif

Alcon (serafilcon A) soft contact lenses for daily wear is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Laboratories, Inc.. It received FDA 510(k) clearance on 2021-12-28 under 510(k) number K212806. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Alcon (serafilcon A) soft contact lenses for daily wear?

Alcon (serafilcon A) soft contact lenses for daily wear is a medical device that received FDA 510(k) clearance on 2021-12-28. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K212806.

When did Alcon (serafilcon A) soft contact lenses for daily wear receive FDA 510(k) clearance?

Alcon (serafilcon A) soft contact lenses for daily wear received FDA 510(k) clearance on 2021-12-28, under 510(k) number K212806.

Who is the listed applicant for Alcon (serafilcon A) soft contact lenses for daily wear?

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

What is the FDA product code for Alcon (serafilcon A) soft contact lenses for daily wear?

The FDA product code for Alcon (serafilcon A) soft contact lenses for daily wear is LPL.

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.

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

Autres dossiers indiquant Alcon Laboratories, Inc. en tant que demandeur

K254052DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal K252682LenSx Laser System (8065000944)K243896LenSx Laser System (8065998162)K243909Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);K233876UNITY VCS (8065000296); UNITY CS (8065000297)

Voir tous les 37 dispositifs →

Dispositifs connexes (Code : LPL)

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.