← Product Code [FSS](/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS) · K970886 # HANAULUX BLUE 80 HOSPITAL (K970886) _Heraeus Med GmbH · FSS · Apr 16, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS/K970886 ## Device Facts - **Applicant:** Heraeus Med GmbH - **Product Code:** [FSS](/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS.md) - **Decision Date:** Apr 16, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4580 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Intended Use Examination and Surgical Stand Light. ## Device Story Hanaulux blue 80 Hospital is an examination and surgical stand light; functions as a light source for clinical procedures. Device design, material, and function are identical to Hanaulux blue 80 Stand, with the addition of a battery supply unit mounted to the stand pole and foot. Battery charges during mains connection; automatically switches to battery power upon mains failure. Used in clinical environments; operated by healthcare personnel. Provides illumination for surgical or examination tasks; ensures continuity of light during power outages. ## Clinical Evidence Bench testing only. Compliance with UL 2601, IEC 601-1, and UL 153 standards for medical electrical equipment and portable electric lamps. UV irradiance verified to be below 6 W/m². ## Technological Characteristics Stand-mounted surgical/examination light. Materials: UL Recognized Component plastics. Wiring: Listed fixture wire or Recognized Component appliance wiring. Power: Mains supply with integrated battery backup unit. Safety: UV irradiance < 6 W/m². Compliance: UL 2601, IEC 601-1, UL 153. ## 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. ## Predicate Devices - HANAULUX City series - HANAULUX 2000 ## Reference Devices - blue 80 Hospital ([K954169](/device/K954169.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [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/). {0} 27.MAR.1997 9:13 HERAEUS-MED ENTW. 06181 355934 No. 339 S.5 Encl. A1 blue 80 Hospital, K954169 K970886 Heraeus MED APR 16 1997 Summary Date: 20. December 1995 Address: HERAEUS MED GmbH Heraeusstraße 12 - 14 63450 Hanau Contact person: Mark Schulz Establishment Registration Number: 8010802 Proprietary Name: HANAULUX blue 30 & 80 Version: HANAULUX blue 80 Hospital Common Name: Examination Light and Surgical Light Device Classification: Regulatory Class II, 79FSY Compliance with Standards: UL 2601 Safety of Medical Electrical Equipment IEC 601-1 Safety of Medical Electrical Equipment UL 153 Portable Electric Lamps Substantial equivalence: This product is similar in funktion to the existing surgical lighting program HANAULUX "City" series and HANAULUX 2000. HME/ FDA001.SAM Seite 1 von 2 {1} 27.MAR.1997 9:13 HERAEUS-MED ENTW. 06181 355934 4.33 5.6 Encl. A2 blue 80 Hospital, K954169 Heraeus MED Description of Device: Hanaulux blue 80 Hospital is an Examination and Surgical Stand Light. The Hanaulux® blue 80 Hospital is principally the same as the Hanaulux® blue 80 Stand in design, material and function. The only difference is that the Hanaulux® blue 80 Hospital is equipped with an additional battery supply unit fitted to the stand pole and stand foot. The batteries will be charged up while the Hanaulux® blue 80 Hospital is connected to a mains supply. In case of a failure of the mains supply the light will be automatically switched over to the battery supply. All used plastics are molded of UL Recognized Component material. All internal wiring is either Listed fixture wire or Recognized Component appliance wiring material. The maximum of UV Irradiance is lower than 6 W / m². Hanaulux® blue 80 Hospital is intended to be installed in accordance with the National Electrical Code. March 24, 1997 Mark Schulz Development Engeneer Electric Construction HME/ FDA001.SAM Seite 2 von 2 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS/K970886](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS/K970886) **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:** Innolitics at https://innolitics.com