← Product Code [FSY](/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY) · K781887

# 9100 DAYSTAR AND 9110 ORBITER PACKAGE (K781887)

_Castle Co. · FSY · Dec 12, 1978 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K781887

## Device Facts

- **Applicant:** Castle Co.
- **Product Code:** [FSY](/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY.md)
- **Decision Date:** Dec 12, 1978
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4580
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory 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.

## Special Controls

*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.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K781887](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K781887)

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