# K021585: Stellar Series Surgical Lights with Hermes

- Pathway: 510(k) (Traditional)
- Applicant: Skytron, Div. the Kmw Group, Inc.
- Decided: Nov 13, 2002 after 183 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Stellar Series Surgical Lights are indicated for use with the Hermes OR Control Center (ORCC). A few examples of the more common surgical procedures are Cardiovascular, Ortho, Neuro, Cysto, Opthalmic, Plastics, Special Procedures, Delivery, Urology, and general surgery. Users of the Stellar Series Surgical Lights with Hermes ORCC are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

Source page: https://510kreport.com/device/K021585
Methodology: https://510kreport.com/methodology