HANAULUX BLUE 80 HOSPITAL
Device Facts
| Record ID | K970886 |
|---|---|
| Device Name | HANAULUX BLUE 80 HOSPITAL |
| Applicant | Heraeus Med GmbH |
| Product Code | FSS · General, Plastic Surgery |
| Decision Date | Apr 16, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4580 |
| Device Class | Class 2 |
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.
Indications for Use
Indicated for use as an examination and surgical light in clinical settings.
Regulatory Classification
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)
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