← Product Code [FSY](/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY) · K891757 # KINETIC MODEL 1000 (K891757) _Kinetic Biomedical Services, Inc. · FSY · Apr 19, 1989 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K891757 ## Device Facts - **Applicant:** Kinetic Biomedical Services, Inc. - **Product Code:** [FSY](/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY.md) - **Decision Date:** Apr 19, 1989 - **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. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K891757](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K891757) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K891757