OptiLite IX Laser Surgery Accessories
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K992866 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The OptiLite IX Laser Surgery Accessories are fiber-optic delivery devices classified as Medical Systems Fiberoptic Devices. These accessories are designed to transmit laser energy from surgical laser systems, including KTP, Nd:YAG, Argon, Diode, Ho:YAG, and Er:YAG, to the surgical site for procedures such as incision, excision, ablation, and coagulation.
Intended for use in clinical and operating room settings, these accessories are supplied as reusable components for attachment to cleared laser systems. The device holds an FDA 510(k) clearance (K992866) under product code GEX, with a classification under Regulation 878.4810 for powered laser surgical instruments. No sterility or single-use designation is specified in the data.
Frequently asked questions
Are these accessories meant for single-use or can they be reused after cleaning and sterilization?
The OptiLite IX Laser Surgery Accessories are designed as reusable components. Since they are not labeled as single-use and are intended for attachment to cleared laser systems, they should be cleaned and sterilized between uses according to standard medical device reprocessing protocols. Always follow manufacturer guidelines for maintenance and sterilization to ensure safety and performance.
What types of laser systems are compatible with these accessories, and what procedures can they be used for?
These accessories are designed to transmit laser energy from multiple surgical laser systems, including KTP, Nd:YAG, Argon, Diode, Ho:YAG, and Er:YAG lasers. They are intended for procedures such as incision, excision, ablation, and coagulation, making them versatile for various surgical applications in clinical and operating room settings.
How are these accessories supplied, and where can they be used?
The OptiLite IX Laser Surgery Accessories are supplied as reusable components meant for attachment to FDA-cleared laser systems. They are intended for use in clinical and operating room environments, where they facilitate the delivery of laser energy during surgical procedures.
Are there any specific storage instructions for these accessories?
While the provided data does not explicitly detail storage instructions, reusable medical devices like these should generally be stored in a clean, dry environment to prevent contamination or damage. Always refer to the manufacturer’s instructions for proper storage and handling to maintain functionality and ensure safety.
What is the regulatory pathway for these accessories, and how were they cleared by the FDA?
The OptiLite IX Laser Surgery Accessories were cleared through the FDA’s 510(k) process, specifically under product code GEX for powered laser surgical instruments. The clearance was granted as substantially equivalent to a predicate device, with a decision made by the FDA’s Skin and Soft Tissue (SU) advisory committee in 1999. The device is classified under Regulation 878.4810.
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: OPTILITE IX LASER SURGERY ACCESSORIES - Innolitics, OPTILITE IX LASER SURGERY ACCESSORIES 510 (k) K992866 - FDA.report, Medical Systems Fiberoptic Devices - Convergent Laser Technologies
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K992866 | Class II | Active |
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Manufacturer
- Manufacturer
- Convergent Laser Technologies
Sources (1)
- FDA 510(k) K992866 24 fields · synced Sep 20, 2026