# K100234: HM-Lamp II

- Pathway: 510(k) (Traditional)
- Applicant: Hillusa, Inc.
- Decided: Jul 8, 2010 after 163 days
- Product code: FTD (Lamp, Surgical)
- 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
Longest line of descent: 1 generation back to K003423 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003423: ST. Francis Operating Theatre Lamp, Models OLH01-125 and LC-055, St. Francis Medical Equipment Co., Ltd. (2001) Summary page 1.

## Indications for use
HM-LAMP II is a device intended to be used to provide visible illumination of the surgical field or the patient. They are designed for minor surgical procedures.

Source page: https://510kreport.com/device/K100234
Methodology: https://510kreport.com/methodology