(77 days)
To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: Ilightsource attaches to fiberoptic cable which is then attached to a headlight or Endoscope. The lightsource supplies light for the headlight or Endoscope.
Lightsource or illuminator CERMAX300
This document is a 510(k) clearance letter from the FDA for a medical device called "Cermax300 Lightsource." It does not contain information about acceptance criteria or specific study details proving the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
Therefore, I cannot extract the requested information as it is not present in the provided text.
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.