(92 days)
The use for this particular device is to be worn on the surgeons head and to illuminate the body cavity during examinations or surgical procedures. This product is shipped to the end user non-sterile.
Surgical Headlight
This is a 510(k) premarket notification for a Surgical Headlight. The provided document is a letter from the FDA determining substantial equivalence to a legally marketed predicate device. It does not contain information about acceptance criteria, device performance studies, or clinical trial data.
Therefore, I cannot provide the requested information. The document is solely an administrative approval letter based on equivalence to existing devices, not a performance evaluation.
§ 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.