# K001746: Lightsheer Pulsed Diode Array Laser System (Family of Products)

- Pathway: 510(k) (Traditional)
- Applicant: Coherent Star
- Decided: Jul 19, 2000 after 41 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
714 later devices descend from it; 9 cite it directly.
0 of 715 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K030805: Mythos 500 (2003), 363 descendants of its own
- K041959: Polaris DS/Comet (2004), 301 descendants of its own
- K053540: Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene (2006), 299 descendants of its own
- K060448: Lumenis One Family of Systems; Lumenis One. (2006), 297 descendants of its own
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own

Source page: https://510kreport.com/device/K001746
Methodology: https://510kreport.com/methodology