Stellaris PC Vision Enhancement System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K101325 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 PC Vision Enhancement System is a phacoemulsification device designed for the emulsification and removal of cataracts, as well as anterior and posterior segment vitrectomy procedures. It combines phacofragmentation capabilities with advanced surgical tools to support both cataract and vitreoretinal surgeries in a single platform.
This system is intended for use in ophthalmic surgical settings and is supplied as a reusable medical device. It is classified under FDA device class 2 and holds a Traditional 510(k) clearance for substantial equivalence in the ophthalmic category. The device is regulated under FDA regulation number 886.4670 and is manufactured by Bausch & Lomb, Inc.
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 PC Vision Enhancement System : Bausch + Lomb, BAUSCH & LOMB STELLARIS PC OPERATOR'S MANUAL Pdf Download, Stellaris Elite™ PC Vision Enhancement System : Bausch + Lomb
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K101325 | Class II | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
Sources (1)
- FDA 510(k) K101325 24 fields · synced Sep 19, 2026