Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens +3 more models
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Boston ES EUDAMED
- Device Name
- Boston ES (enflufocon A) Rigid Gas Permeable Contact Lenses EUDAMED
- Model / Reference
- Spec0300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 0196527M0063H2 EUDAMED
- Basic UDI-DI
- 0310119B0032Z4 EUDAMED
- 510(k) Number
- K183167 FDA 510(k)
- FDA Product Code
- HQD FDA 510(k)
- EMDN Code
- Q02100402 CONTACT LENSES - NON HYDROGEL EUDAMED
- Models / Variants
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.5916 FDA 510(k)
- Regulation Number
- 886.5916 FDA 510(k)
- Special Device Type
- Standard Rigid Gas Permeable (RGP) Contact Lenses EUDAMED
- Market of Registration
- Ireland EUDAMED
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Boston ES, EO, XO, and XO2 are rigid gas permeable contact lenses designed for daily wear. These lenses are intended for the correction of refractive ametropia, including myopia, astigmatism, and presbyopia, in both aphakic and non-aphakic individuals with non-diseased eyes. They may also be prescribed for irregular corneal conditions requiring a gas permeable lens. The lenses are manufactured from enflufocon A, enflufocon B, or hexafocon materials, providing high oxygen permeability and durability for extended wear comfort.
These lenses are supplied as single-use, sterile disposable contact lenses. They are classified as Class II medical devices under FDA regulations and are authorized through 510(k) clearance and EU MDR compliance. The lenses are intended for use in clinical ophthalmic settings and must be handled and stored according to manufacturer instructions to maintain sterility and performance. Sizes and prescriptions are tailored to individual patient requirements, ensuring proper fit and vision correction.
Frequently asked questions
Are these contact lenses designed for overnight wear or only daily use?
These lenses are explicitly designed for daily wear only, not for overnight or extended wear. The manufacturer emphasizes high oxygen permeability and durability for extended daily comfort, but they are not intended for continuous wear beyond the prescribed daily schedule.
How are these lenses supplied, and do they require any special handling to maintain sterility?
The Boston ES, EO, XO, and XO2 lenses are supplied as single-use, sterile disposable contact lenses. To maintain sterility and performance, they must be handled and stored according to the manufacturer’s instructions, which likely include keeping them in sealed packaging until use and avoiding contamination.
Can these lenses be used for patients with irregular corneal conditions, and if so, how?
Yes, these lenses may be prescribed for patients with irregular corneal conditions that require a rigid gas permeable (RGP) lens. The design allows for customization to fit specific corneal irregularities, ensuring proper alignment and vision correction. However, fitting must be performed by an eye care professional based on individual patient requirements.
What materials are these lenses made from, and how does that affect their performance?
The lenses are manufactured from enflufocon A, enflufocon B, or hexafocon materials, all of which provide high oxygen permeability and durability. This composition supports extended daily wear comfort while maintaining clarity and structural integrity, making them suitable for correcting refractive errors like myopia, astigmatism, and presbyopia.
Are these lenses available in multiple sizes or prescriptions, and how are they tailored to patients?
Yes, these lenses come in tailored sizes and prescriptions to fit individual patient needs. The design ensures proper fit and vision correction for both aphakic (without a natural lens) and non-aphakic (with a natural lens) eyes, as well as for irregular corneal conditions. Customization is performed by an eye care professional based on diagnostic measurements.
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: Boston® Materials Professional | Boston® EO® & Boston® ES®, Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO ..., Boston Contact Lenses | Lens.com
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K183167 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bausch & Lomb Incorporated
- FDA Applicant
- Bausch & Lomb, Incorporated
Sources (2)
- FDA 510(k) K183167 24 fields · synced Sep 18, 2026
- EUDAMED 460e6aab-5f8a-4798-b853-b2b1901db353 61 fields · synced Aug 3, 2026