Shiny RPL System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Ids Ltd.
Identifiers
- 510(k) Number
- K181868 FDA 510(k)
- FDA Product Code
- ONF 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 Shiny RPL System is a powered, light-based non-laser surgical instrument with thermal effects, classified under FDA product code ONF for general and plastic surgery applications. It is designed to provide controlled thermal energy for surgical procedures, offering an alternative to traditional laser systems while maintaining precision and efficacy in tissue treatment.
This device is supplied as a reusable medical instrument, regulated under 21 CFR 878.4810, and has received FDA 510(k) clearance through the Traditional pathway. Authorized for use in sterile surgical settings, it is intended for professional medical environments and adheres to Class II regulatory standards. No specific MRI safety or single-use indications are noted in the available data.
Frequently asked questions
What types of surgical procedures is the Shiny RPL System intended for, and why is it considered an alternative to traditional laser systems?
The Shiny RPL System is designed for general and plastic surgery applications, specifically as a powered, light-based non-laser instrument with thermal effects. It provides controlled thermal energy as an alternative to traditional laser systems, offering precision and efficacy in tissue treatment while avoiding the use of lasers. This makes it suitable for procedures where thermal effects are beneficial but laser-specific risks (e.g., collateral damage, smoke production) are undesirable.
Is the Shiny RPL System single-use or reusable, and what does this mean for its maintenance and sterilization?
The Shiny RPL System is a reusable medical instrument, as explicitly stated in the device data. This means it must be cleaned, inspected, and sterilized between uses in accordance with facility protocols for reusable surgical devices. Since it is intended for sterile surgical settings, proper sterilization (e.g., autoclave or ethylene oxide) is required to ensure safety and prevent cross-contamination.
How was the Shiny RPL System’s regulatory pathway determined, and what does this tell buyers about its approval status?
The Shiny RPL System was cleared through the FDA 510(k) Traditional pathway, meaning its manufacturer (IDS Ltd.) demonstrated that it is substantially equivalent to a legally marketed predicate device. This pathway confirms the device meets FDA safety and effectiveness standards for Class II medical devices under product code ONF (General and Plastic Surgery). The clearance date (October 5, 2018) and the use of the Traditional pathway indicate a thorough review process, though it does not imply ongoing post-market surveillance beyond standard regulatory requirements.
Are there any specific storage requirements for the Shiny RPL System, and why might this matter for clinical use?
While the device data does not specify exact storage conditions (e.g., temperature, humidity), the Shiny RPL System is intended for sterile surgical settings and classified as a reusable instrument. Proper storage—such as in a clean, dry environment protected from contamination—is critical to maintain sterility and functionality between uses. Clinicians should follow manufacturer guidelines (available upon request) to ensure the device remains ready for surgical procedures without degradation or risk of infection.
What does the mention of ‘thermal effects’ imply about how the Shiny RPL System interacts with tissue, and how does this differ from non-thermal surgical tools?
The ‘thermal effects’ of the Shiny RPL System indicate it delivers controlled heat to tissue during surgery, which can facilitate procedures like coagulation, cutting, or tissue ablation. Unlike non-thermal tools (e.g., cold steel scalpels or ultrasonic devices), thermal energy allows for precise tissue modification without the risks associated with lasers (e.g., deep tissue burns or smoke). This makes it particularly useful in surgeries where gentle yet effective tissue manipulation is required, such as in plastic or reconstructive procedures.
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: K181868 FDA 510 (k) - SHINY RPL System | Ids, Ltd., SHINY RPL System (K181868) — FDA 510 (k) | Innolitics, SHINY RPL System 510 (k) K181868 - FDA.report
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K181868 | Class II | Active |
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Manufacturer
- Manufacturer
- Ids Ltd.
- FDA Applicant
- Ids, Ltd.
Sources (2)
- FDA 510(k) K181868 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026