(203 days)
The Surgical light. CHROMOPHARE®D-650. is intended to illuminate locally the operating site on the patient's body with a high light intensity. "cold" light.
Surgical light. CHROMOPHARE®D-650.
I am sorry, but the provided text does not contain the acceptance criteria, study details, or performance data for the CHROMOPHARE®D-650 surgical light. The document is a 510(k) clearance letter from the FDA, which indicates that the device has been found substantially equivalent to a predicate device and can be legally marketed. It discusses regulatory classifications, general controls, and compliance requirements, but it does not include performance specifications or the results of any specific studies demonstrating how the device meets acceptance criteria.
The only performance-related information is a brief "Indication for Use" stating that the device "is intended to illuminate locally the operating site on the patient's body with a high light intensity, 'cold' light." This is a functional description, not a set of measurable acceptance criteria with corresponding study results.
§ 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.