# K023004: Lfre Indirect Laryngoscope

- Pathway: 510(k) (Traditional)
- Applicant: Astralite Corp.
- Decided: Jan 28, 2003 after 141 days
- Product code: EOB (Nasopharyngoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4760
- 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 no predicate by number.

## Indications for use
The LFRE Indirect Laryngoscope may be used for examinations of the larynx and pharynx 1 while conducting normal, routine physical examinations. 2. while inspecting for causes of abnormal conditions (e.g., hoarseness, pain) presented by the patient. 3. while inspecting for causes of abnormal conditions indicated by referring facilities.

Source page: https://510kreport.com/device/K023004
Methodology: https://510kreport.com/methodology