# K994362: Headlamp HL2000.

- Pathway: 510(k) (Traditional)
- Applicant: Angiolaz, Inc.
- Decided: May 11, 2000 after 136 days
- Product code: FSR (Light, Headband, Surgical)
- Device class: 2
- Regulation: 21 CFR 886.4335
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Headlamp HL2000 has indicated use in the following situations: There is a requirement for illuminating a surgical field. The doctor wears this device on his/her head. A fiber-optic light cable is connected at one end to a remote light source and the other end to the headlamp. The headlamp contains a lens system that directs the light into a circular spot and illuminates the surgical field.

Source page: https://510kreport.com/device/K994362
Methodology: https://510kreport.com/methodology