Stellaris Elite Vision Enhancement System
FDA 510(k)Class II (US FDA 510(k))
by Bausch+Lomb
Identifiers
- 510(k) Number
- K162342 FDA 510(k)
- FDA Product Code
- HQC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.4670 FDA 510(k)
- Regulation Number
- 886.4670 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Stellaris Elite Vision Enhancement System is a combined phacoemulsification and vitrectomy system designed for the emulsification and removal of cataracts, as well as anterior and posterior segment vitrectomy. It is intended for use in both anterior and posterior segment surgeries.
The device is supplied as a single-use system. It is not indicated for use in MRI environments. The system is regulated under FDA 510(k) clearance (K162342).
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: Stellaris Elite - Bausch Surgical, Home Page - Stellaris Elite, PDF STELLARIS ELITE SPECIFICATIONS - Bausch Surgical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162342 | Class II | Active |
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Manufacturer
- Manufacturer
- Bausch+Lomb
Sources (1)
- FDA 510(k) K162342 24 fields · synced Sep 22, 2026