# K812219: Model 900S Intraocular Probe

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Inc.
- Decided: Nov 16, 1981 after 102 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
297 later devices descend from it; 1 cites it directly.
0 of 298 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
- K991258: Novus Verdi Delivery Systems (1999), 296 descendants of its own
- K050738: FT Fiber Optic Delivery Systems (2005), 225 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own

Source page: https://510kreport.com/device/K812219
Methodology: https://510kreport.com/methodology