ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K142638 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 ProFlex Laser Fibers (ProFlex 200 and ProFlex 273) are laser delivery systems designed for surgical applications, specifically optimized for holmium laser lithotripsy and litholysis. These fibers utilize a proprietary lens in the connector to condition and collimate laser energy, ensuring precise and efficient energy transfer during procedures. The device is categorized under GEX (General, Plastic Surgery) product codes and is intended for use with various surgical lasers in controlled clinical settings. Their construction incorporates high-performance optical fibers to enhance durability and performance in demanding procedures.
These fibers are single-use, sterile, and non-MRI-compatible devices supplied in sterile packaging for immediate clinical use. The ProFlex 200 features a 200-micron core, while the ProFlex 273 has a 273-micron core, catering to different procedural requirements. They are regulated under FDA 510(k) clearance (K142638) and classified as substantially equivalent to predicate devices. Storage should follow manufacturer guidelines to maintain sterility and performance until use.
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: ProFlex Fibers | Innovaquartz LLC | United States, ProFlex Holmuim Laser Fibers - BD, LASER FIBERS - Fibers — Reliable Laser Solutions
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142638 | Class II | Active |
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Manufacturer
- Manufacturer
- Innovaquartz, LLC
Sources (1)
- FDA 510(k) K142638 24 fields · synced Oct 1, 2026