# K973466: Hanaulux Blue 75 and Hanaulux Blue 120

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Med GmbH
- Decided: Oct 24, 1997 after 70 days
- Product code: FSY (Light, Surgical, Ceiling Mounted)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) HANAULUX "City" series: named in the summary without a submission number
- (no number) Hanaulux 2000: named in the summary without a submission number
- (no number) HANAULUX blue 30 / 80: named in the summary without a submission number

## Indications for use
Hanaulux blue 75 / 120 are surgical luminaires used in the patient area and intended to illuminate locally the body of the patient. They are installed as a system of one, two or three luminaires and are intended to support the treatment and diagnosis. They are intended to be used in operating rooms and not for direct contact with patient.

Source page: https://510kreport.com/device/K973466
Methodology: https://510kreport.com/methodology