# K022760: Millennium Microsurgical System

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Inc.
- Decided: Nov 18, 2002 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.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) IRIS Medical OcuLight GL Laser System: named in the summary without a submission number
- (no number) Millennium Microsurgical System: named in the summary without a submission number

## Most influential descendants
- K133486: Stellaris PC Vision Enhancement System (2014), 7 descendants of its own
- K190875: EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) (2019), 2 descendants of its own
- K213467: EVA NEXUS Ophthalmic Surgical System (2022), 1 descendant of its own
- K170052: Stellaris Elite vision enhancement system (2017), 1 descendant of its own
- K162342: Stellaris Elite Vision Enhancement System (2017), 1 descendant of its own

## Indications for use
The laser modes are intended for retinal photocoagulation and laser trabeculaplasty. Delivery devices available are the Endoprobe for intraocular endolaser surgery, and the Laser Indirect Ophthalmoscope Plus (LIO+) for transpupillary laser delivery for patients in the supine position.

Source page: https://510kreport.com/device/K022760
Methodology: https://510kreport.com/methodology