# K031549: Solid State Lamp [Led] Headlight

- Pathway: 510(k) (Abbreviated)
- Applicant: Welch Allyn, Inc.
- Decided: Aug 11, 2003 after 87 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. The FDA summary names its predicate without a number.
- (no number) Direct Focusing Headlight: named in the summary without a submission number

## Indications for use
The Solid State Portable Headlight is indicated for providing a portable, battery powered illumination for performing general exams, foreign body removal, and minor suturing.

Source page: https://510kreport.com/device/K031549
Methodology: https://510kreport.com/methodology