# K004006: Selecta 7000 Frequency Doubled, Q-Switched ND:Yag Ophthalmic Laser

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Inc.
- Decided: Mar 26, 2001 after 90 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K051944: Family of Selecta Ophthalmic Laser Systems (Selecta 1064, Selecta SLT, Selecta Duo), Delivery Device and Accessories (2005), 1 descendant of its own
- K060338: Family of Selecta Laser Systems Including Selecta 1064, Selecta SLT, Selecta  Duet, Selecta Duo, Selecta Trio (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K004006
Methodology: https://510kreport.com/methodology