# K913569: Compac a, Elite a, Elite a Plus, Surgica a

- Pathway: 510(k) (Traditional)
- Applicant: Hgm Medical Laser Systems, Inc.
- Decided: Oct 17, 1991 after 69 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 2 cite it directly.
0 of 25 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
- K982031: Oculight GL with the Dermatology Handpiece (1998), 22 descendants of its own
- K031665: Iris Medical Oculight GL/GLX Laser Systems (2003), 21 descendants of its own
- K062624: Next Generation Laser (2007), 18 descendants of its own
- K101285: Constellation Vision System (2010), 17 descendants of its own
- K121555: Centurion Vision System (2012), 6 descendants of its own

## Recalls of this device
- Feb 1, 2006 · Not classified · Z-0545-06: The BP/Notch filter may be out of specification and may cause injury to the patient's eye due to high power (energy) delivered by the Laser System during medical procedures.

Source page: https://510kreport.com/device/K913569
Methodology: https://510kreport.com/methodology