Cleared Abbreviated

K153714 - 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

K153714 is an FDA 510(k) clearance for SynergEyes A&M (paflufocon D hem-iberfi..., manufactured by Synergeyes, Inc.. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Abbreviated 510(k) pathway after a 327-day FDA review.

K153714 · Synergeyes, Inc. · Ophthalmic device
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Nov 2016
Decision
327d
Days
Class 2
Risk

K153714 is an FDA 510(k) clearance for the SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens.... Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Synergeyes, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 15, 2016 after a review of 327 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5916 - the FDA ophthalmic device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Synergeyes, Inc. devices

FDA 510(k) Submission Details - K153714

510(k) Number K153714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2015
Decision Date November 15, 2016
Days to Decision 327 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
217d slower than avg
Panel avg: 110d · This submission: 327d
Pathway characteristics
Standards-based clearance path.

HQD Device Classification - Class 2, Special Controls

Product Code HQD Lens, Contact (other Material) - Daily
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5916
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Consultant

R.E. Lippman Regulatory Pathways
Richard E. Lippman

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HQD Lens, Contact (other Material) - Daily

All 82
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