Synergeyes SIG (Petrafocon A Hem-Larafilcon A) Hybrid Contact Lens
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K083921 FDA 510(k)
- FDA Product Code
- HQD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.5916 FDA 510(k)
- Regulation Number
- 886.5916 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Synergeyes SIG (Petrafocon A Hem-Larafilcon A) Hybrid Contact Lens is a hybrid contact lens combining a rigid gas permeable (RGP) center made of Petrafocon A with a soft silicone-hydrogel skirt of Hem-Larafilcon A. This design is classified as a contact lens (other material) for daily wear, designed to correct refractive errors by straddling the limbus and focusing light onto the retina.
This device is intended for daily wear and is supplied as a single-use product. It is regulated under FDA 510(k) clearance (K083921) and falls under device classification II (HQD product code). The lens is not MRI-safe, and specific sizes are determined by the prescription requirements of the wearer. Storage and handling follow standard ophthalmic contact lens protocols as per regulatory guidelines.
Frequently asked questions
What is the primary purpose of the Synergeyes SIG hybrid contact lens, and how does its design differ from traditional contact lenses?
The Synergeyes SIG hybrid contact lens is designed to correct refractive errors by combining a rigid gas permeable (RGP) center made of Petrafocon A with a soft silicone-hydrogel skirt of Hem-Larafilcon A. Unlike traditional soft or rigid lenses, this hybrid design straddles the limbus, allowing the RGP center to provide sharp vision while the soft skirt enhances comfort and stability on the eye. It is specifically classified as a daily-wear contact lens for general refractive correction.
Is the Synergeyes SIG hybrid contact lens intended for reuse, or is it meant to be used only once?
The Synergeyes SIG hybrid contact lens is explicitly supplied as a single-use product, meaning each lens is intended for one-time wear only. This aligns with standard daily-wear contact lens protocols to ensure safety, hygiene, and optimal performance for the wearer.
How are the sizes of the Synergeyes SIG hybrid contact lenses determined, and can they be adjusted for different prescriptions?
The sizes of the Synergeyes SIG hybrid contact lenses are not fixed but are instead tailored to the prescription requirements of the wearer. Since it is a custom-fitted device, the specific diameter and curvature are determined based on the individual’s corneal measurements and refractive needs, ensuring proper alignment and vision correction.
What storage and handling guidelines should be followed for the Synergeyes SIG hybrid contact lens?
Storage and handling of the Synergeyes SIG hybrid contact lens follow standard ophthalmic contact lens protocols as outlined by regulatory guidelines. This typically includes proper cleaning, disinfection, and storage in a sterile, sealed case to maintain sterility and prevent contamination before use. Always adhere to the manufacturer’s instructions and clinical best practices.
Can the Synergeyes SIG hybrid contact lens be used safely in an MRI environment, or are there any restrictions?
The Synergeyes SIG hybrid contact lens is explicitly not MRI-safe, meaning it should not be used during MRI procedures. The materials and design may interact with magnetic fields, posing a risk to both the lens and the patient. Always verify compatibility with imaging modalities before use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Synergeyes Sig (Petrafocon a Hem-larafilcon A) Hybrid Contact Lens ..., Synergeyes Sih (Petrafocon a Hem-larafilcon A) Hybrid Contact Lens, Synergeyes Sih (Petrafocon a Hem-larafilcon A) Hybrid Contact Lens, PDF SynergEyes® iD Single Vision and SynergEyes iD Multifocal EDOF
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K083921 | Class II | Active |
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Manufacturer
- Manufacturer
- Synergeyes, Inc.
Sources (1)
- FDA 510(k) K083921 24 fields · synced Oct 6, 2026