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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Contact (Other Material) - Daily
510(k) Number K153714
Device Name SynergEyes 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
Applicant
Synergeyes, Inc.
5927 Priestly Dr., Suite210
Carlsbad,  CA  92008
Applicant Contact Karen Kincade
Correspondent
R.E. Lippman Regulatory Pathways
1171 Kersey Rd.
Silver Spring,  MD  20902
Correspondent Contact Richard E. Lippman
Regulation Number886.5916
Classification Product Code
HQD  
Date Received12/24/2015
Decision Date 11/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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