Stellaris Microsurgical System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K082473 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 Microsurgical System is a phacofragmentation device designed for ophthalmic microsurgery. It employs ultrasonic technology to emulsify and remove cataracts or other intraocular materials, facilitating precise lens replacement procedures.
The system is supplied as a reusable medical device, intended for use in sterile operating environments by trained ophthalmic surgeons. It is classified under FDA Class II and includes multiple model variants (e.g., FEI numbers 1000120314, 3006695864) for compatibility with various surgical applications. No MRI safety or single-use indications are specified.
Frequently asked questions
What types of surgical procedures is the Stellaris Microsurgical System designed to assist with, and how does it work?
The Stellaris Microsurgical System is specifically designed for ophthalmic microsurgery, particularly for phacofragmentation—emulsifying and removing cataracts or other intraocular materials. It uses ultrasonic technology to break down dense materials into smaller particles, allowing for precise lens replacement or other intraocular procedures. This makes it ideal for cataract surgery and similar interventions where tissue must be carefully removed.
Is the Stellaris Microsurgical System intended for single-use or reusable applications, and how should it be maintained?
The Stellaris Microsurgical System is explicitly supplied as a reusable medical device. Since it is intended for sterile operating environments, it must be thoroughly cleaned, disinfected, and maintained according to manufacturer guidelines to ensure safety and functionality between uses. Proper sterilization protocols are critical to prevent contamination during surgical procedures.
What model variants or configurations are available for the Stellaris Microsurgical System, and how do they differ?
The Stellaris Microsurgical System includes multiple model variants, each associated with specific FEI numbers (e.g., 1000120314, 3006695864, etc.). While the exact differences between these models are not detailed in the provided data, the variety suggests compatibility with different surgical techniques, accessories, or procedural requirements within ophthalmic microsurgery. Always verify compatibility with your intended use case.
How was the Stellaris Microsurgical System evaluated by the FDA, and what does the clearance type indicate?
The Stellaris Microsurgical System received FDA clearance via a 510(k) submission, classified as Substantially Equivalent (SE) under the Abbreviated (SESE) decision code. This means the FDA determined it is as safe and effective as a legally marketed predicate device (a comparable phacofragmentation system) and falls under FDA Class II, requiring special controls but not premarket approval. The clearance was granted by the Ophthalmic (OP) Advisory Committee.
Are there any special storage or handling requirements for the Stellaris Microsurgical System before use?
While specific storage instructions aren’t detailed in the provided data, as a reusable surgical device intended for sterile environments, the Stellaris Microsurgical System should be stored in a clean, dry location away from direct sunlight or extreme temperatures. Before use, it must undergo proper cleaning, disinfection, and sterilization to meet surgical standards. Always follow the manufacturer’s instructions for preparation.
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: Bausch + Lomb Official Home Page, Stellaris Elite - Bausch Surgical, Anmelden | Bausch Germany MC Site, Stellaris Elite - 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 | K082473 | Class II | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
Sources (1)
- FDA 510(k) K082473 24 fields · synced Sep 18, 2026