# K003614: Lightsheer Pulsed Diode Array Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Coherent Star
- Decided: Mar 13, 2001 after 111 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
728 later devices descend from it; 10 cite it directly.
0 of 729 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

## Recalls of this device
- Mar 25, 2015 · Class II · Z-1519-2015: Device software treatment preset parameters for the XC treatment handpiece do not match the Operator Manual, and exceed recommended settings. Operator Manual parameters are lower than indicated for sp
- Feb 9, 2006 · Not classified · Z-0556-06: During hair removal treatment, patients' skin can experience burns due to debris accumulating on the sapphire crystal tip.

Source page: https://510kreport.com/device/K003614
Methodology: https://510kreport.com/methodology