Indigo Optima Laser System, Optima Diffuser-Tip Fiberoptic-Bph, Optima Bare-Tip…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K023182 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 Indigo Optima Laser System is a laser-based device classified as a Laser, Surgical (FDA Product Code: GEX) for tissue ablation and coagulation. It employs fiberoptic delivery systems—including a diffuser-tip for interstitial laser coagulation and a bare-tip for direct tissue interaction—to treat benign prostatic hyperplasia (BPH) by vaporizing or coagulating prostatic tissue, thereby relieving urinary obstruction.
The system is supplied as a reusable laser cart with printed components and requires FDA-cleared (510K K023182) integration with the fiberoptic attachments. Sterility is not specified; the diffuser-tip and bare-tip fiberoptics are intended for single-use per procedure. No MRI safety information is provided. Storage and handling follow standard laser device protocols as outlined in the manufacturer’s instructions.
Frequently asked questions
What is the Indigo Optima Laser System used for?
The Indigo Optima Laser System is designed for tissue ablation and coagulation in surgical procedures, specifically targeting benign prostatic hyperplasia (BPH). It vaporizes or coagulates prostatic tissue to relieve urinary obstruction caused by an enlarged prostate. The system employs two fiberoptic attachments—a diffuser-tip for interstitial laser coagulation and a bare-tip for direct tissue interaction—to achieve precise treatment.
How is the Indigo Optima Laser System supplied?
The system is supplied as a reusable laser cart that includes printed components. It requires FDA-cleared integration with the fiberoptic attachments (510K K023182) to function. The diffuser-tip and bare-tip fiberoptics are intended for single-use per procedure, while the laser cart itself is designed for reuse across multiple procedures.
Are the fiberoptic attachments sterile?
The manufacturer does not specify sterility for the fiberoptic attachments. Since they are intended for single-use per procedure, it is critical to follow standard medical device handling and preparation protocols to ensure patient safety. Always refer to the manufacturer’s instructions for proper use and preparation.
Can the Indigo Optima Laser System be used in MRI environments?
No MRI safety information is provided for the Indigo Optima Laser System. If MRI compatibility is required, additional precautions or alternative devices should be considered. Always verify compatibility with the specific MRI system and consult the manufacturer’s guidelines for safe use.
How should the Indigo Optima Laser System be stored?
Storage and handling of the Indigo Optima Laser System should adhere to standard protocols for laser devices as outlined in the manufacturer’s instructions. This includes protecting the reusable laser cart from physical damage, ensuring proper environmental conditions (e.g., temperature, humidity), and storing single-use fiberoptic attachments in a way that maintains their integrity until use. Avoid exposure to direct sunlight or extreme temperatures.
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: IndiGo - Book Domestic and International Flights at Lowest Airfare, Indigo Optima Laser System, Optima Diffuser-tip Fiberoptic-bph, Optima ..., indigo optima laser system optima diffuser-tip fiberoptic-bph optima ..., IndiGo - Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K023182 | Class II | Active |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, Inc.
Sources (1)
- FDA 510(k) K023182 24 fields · synced Oct 1, 2026