Identifiers
- 510(k) Number
- K012096 FDA 510(k)
- FDA Product Code
- HJK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1385 FDA 510(k)
- Regulation Number
- 886.1385 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Disposable Vitrectomy Lens is a diagnostic contact lens made of polymethylmethacrylate (PMMA), designed for use during vitrectomy procedures. It provides optically clear visualization of the posterior segment of the eye, facilitating intraocular examination and surgical intervention.
Supplied as a single-use device in sterile peel packs, these lenses are packaged in boxes of ten. The lens features a silicone flange and a flexible thermoplastic elastomer (TPE) ring with three molded haptics to ensure stable positioning on the eye. Authorized under FDA 510(k) clearance (K012096), it adheres to Class II regulatory standards for ophthalmic diagnostic contact lenses.
Frequently asked questions
What is the Disposable Vitrectomy Lens used for?
The Disposable Vitrectomy Lens is a diagnostic contact lens designed for use during vitrectomy procedures to provide optically clear visualization of the posterior segment of the eye, facilitating intraocular examination and surgical intervention.
How is the Disposable Vitrectomy Lens supplied?
The lens is supplied as a single-use device in sterile peel packs, with each box containing ten lenses. It features a silicone flange and a flexible thermoplastic elastomer ring with three molded haptics for stable positioning on the eye.
Is the Disposable Vitrectomy Lens reusable?
No, the Disposable Vitrectomy Lens is designed as a single-use device and should not be reused. It is supplied in sterile peel packs to maintain sterility for each use.
What material is the Disposable Vitrectomy Lens made of?
The Disposable Vitrectomy Lens is made of polymethylmethacrylate (PMMA), which provides the optical clarity necessary for visualization during vitrectomy procedures.
What is the regulatory status of the Disposable Vitrectomy Lens?
The Disposable Vitrectomy Lens is authorized under FDA 510(k) clearance (K012096) and adheres to Class II regulatory standards for ophthalmic diagnostic contact lenses.
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: Disposable Vitrectomy Lenses - Direct Vitrectomy Lenses - Vitrectomy ..., BVI Medical - Disposable Vitrectomy Lenses, Disposable Vitrectomy lenses - FCI
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K012096 | Class II | Active |
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Manufacturer
- Manufacturer
- Ocular Instruments, Inc.
Sources (1)
- FDA 510(k) K012096 24 fields · synced Sep 19, 2026