Synergeyes PS Hybrid Contact Lens
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K060102 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 PS Hybrid Contact Lens is a contact lens designed for patients with presbyopia, combining a rigid gas-permeable center with a soft peripheral skirt. This hybrid design aims to provide clear, stable vision while accommodating age-related near-vision difficulties, offering a balance between optical precision and comfort for daily wear.
This device is supplied as a single-use contact lens and is intended for ophthalmic use only. It is classified as a Class II medical device under FDA regulations and has received 510(k) clearance. The lens is available in various sizes and prescriptions, adhering to FDA-mandated registration numbers and product codes (e.g., HQD). Sterility and packaging details are not specified but must comply with FDA standards for contact lens distribution.
Frequently asked questions
What is the Synergeyes PS Hybrid Contact Lens designed to address in patients?
The Synergeyes PS Hybrid Contact Lens is specifically designed for patients with presbyopia, which is the age-related loss of the eye’s ability to focus on close objects. Its hybrid design—combining a rigid gas-permeable center for optical clarity with a soft peripheral skirt for comfort—aims to provide stable vision correction while accommodating near-vision challenges, making it suitable for daily wear.
How is the Synergeyes PS Hybrid Contact Lens supplied, and is it reusable?
The Synergeyes PS Hybrid Contact Lens is supplied as a single-use device, meaning each lens is intended for one-time wear only. This aligns with FDA standards for contact lens distribution and ensures hygiene and safety for patients. Reuse is not recommended or supported by the manufacturer.
Are there multiple sizes or prescriptions available for this contact lens?
Yes, the Synergeyes PS Hybrid Contact Lens is available in various sizes and prescriptions to accommodate different patient needs. The exact range of diopters or base curves isn’t specified in the data, but the device’s FDA clearance (K060102) and associated registration numbers (e.g., 3010607087) reflect its approval for multiple configurations under the product code HQD (Ophthalmic Contact Lenses, Daily Wear).
What regulatory pathway did the Synergeyes PS Hybrid Contact Lens follow to gain market authorization?
The Synergeyes PS Hybrid Contact Lens received FDA 510(k) clearance through a traditional review process, classified as a Class II medical device. The submission was reviewed by the Ophthalmic Devices (OP) Advisory Committee, and the decision was based on a determination of substantial equivalence to a predicate device. The clearance date is March 15, 2006, with the 510(k) number listed as K060102.
How should the Synergeyes PS Hybrid Contact Lens be stored, and are there any special handling instructions?
While the exact storage instructions aren’t detailed in the provided data, as a single-use contact lens, it must comply with FDA standards for sterility and packaging. Typically, such lenses are stored in sealed, sterile packaging until use, protected from contamination. Patients or clinicians should follow the manufacturer’s included instructions (not provided here) for optimal handling, including avoiding exposure to moisture or direct light 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, SynergEyes A, KC, PS, MF, The Complete Guide to SynergEyes Hybrid Contact Lenses, PDF SynergEyes® PS (paflufocon D - hem-iberfilcon A) HYBRID CONTACT LENS ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K060102 | Class II | Active |
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Manufacturer
- Manufacturer
- Synergeyes, Inc.
Sources (1)
- FDA 510(k) K060102 24 fields · synced Oct 6, 2026