Super View Disposable Biom Lens Set
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K051630 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 Super View Disposable Biom Lens Set is a diagnostic lens set consisting of sterile, disposable thermoplastic lenses used in conjunction with an operating microscope equipped with a BIOM wide-angle viewing system. It provides surgical optics to improve visualization of ocular fundus, vitreous, and retinal structures during vitreoretinal surgery. The lens set includes a disposable, rotatable lens holder with options for viewing the vitreous cavity and retina.
The Super View Disposable Biom Lens Set is supplied sterile and is intended for single-use. It is available in multiple configurations, including a wide field lens for viewing the entire fundus and far periphery, and an Ultra HD wide field lens for higher magnification views. The device has been authorized with an FDA 510K clearance and is classified as a class 2 device with the regulation number 886.1385.
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: SUPER VIEW DISPOSABLE BIOM LENS SET - Innolitics, PDF Super View Disposable Lens Set, PIVOT™ - oculussurgical.com, PDF Z005 K vS &30 Insight Instruments, Inc. - accessdata.fda.gov
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K051630 | Class II | Active |
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Manufacturer
- Manufacturer
- Insight Instruments, Inc.
Sources (1)
- FDA 510(k) K051630 24 fields · synced Sep 26, 2026