FDA 510(k)

SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens

Número K: K160938 · 2016-08-01

Data da decisão2016-08-01

Código do produtoHQD

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens is the device name listed in this FDA 510(k) record. The listed applicant is Synergeyes, Inc.. It received FDA 510(k) clearance on 2016-08-01 under 510(k) number K160938. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens?

SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens is a medical device that received FDA 510(k) clearance on 2016-08-01. The listed applicant is Synergeyes, Inc.. The 510(k) number is K160938.

When did SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens receive FDA 510(k) clearance?

SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens received FDA 510(k) clearance on 2016-08-01, under 510(k) number K160938.

Who is the listed applicant for SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens?

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

What is the FDA product code for SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens?

The FDA product code for SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens is HQD.

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Outros registros que listam Synergeyes, Inc. como candidato(a)

K153714SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens, SynergEyes UltraHealth for Keratoconus (petrafocon A hem-larafilcon A) Hybrid Daily Wear Co

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