Startrol LED Lighting Systems Model X X Y -N-S-W
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K100702 FDA 510(k)
- FDA Product Code
- FSY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4580 FDA 510(k)
- Regulation Number
- 878.4580 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is a surgical ceiling-mounted light system, as defined by its device type and nomenclature. It consists of multiple light pods and LEDs configured for surgical illumination, with the model designation indicating the number of pods (X), number of LEDs per pod (Y), and mounting style (N).
The system is supplied as a reusable surgical lighting system intended for use in general and plastic surgery settings. It received FDA 510(k) clearance (K100702) as substantially equivalent to a predicate device, and is classified as a Class II medical device under regulation number 878.4580.
Frequently asked questions
What is the STARTROL LED Lighting System used for?
The STARTROL LED Lighting System is intended for surgical illumination in general and plastic surgery settings, providing adjustable lighting via multiple light pods and LEDs mounted on the ceiling to support visualization during procedures.
How is the STARTROL LED Lighting System supplied and is it reusable?
The system is supplied as a reusable surgical lighting system, meaning it is designed for repeated use after proper cleaning and maintenance, not as a single-use device, and consists of multiple light pods and LEDs configured for ceiling mounting in operating rooms.
What does the model designation X X Y -N-S-W indicate for the STARTROL LED Lighting System?
The model designation indicates the number of light pods (X), the number of LEDs per pod (Y), and the mounting style (N), allowing customization of the system based on the number of pods, LED density per pod, and how it is attached to the ceiling.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K100702 | Class II | Active |
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Manufacturer
- Manufacturer
- Huot Instruments, Llc
Sources (1)
- FDA 510(k) K100702 24 fields · synced Oct 6, 2026