510(k) · Cleared
Recalled · 2006Compac a, Elite a, Elite a Plus, Surgica a
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hgm Medical Laser Systems, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Oct 17, 1991 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 24 later devices descend from it. It has been recalled once.
- Decided
- Oct 17, 1991
- Review
- 69 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 1
- Predicates
- 0
24 later devices descend from it, 2 citing it directly.
- This deviceK913569 Compac a, Elite a, Elite a Plus, Surgica aHgm Medical Laser Systems, Inc. · 1991
- Descendant · cites it directly · 22 of its ownK982031 Oculight GL with the Dermatology HandpieceIridex Corp · 1998
- Descendant · 2 generations on · 21 of its ownK031665 Iris Medical Oculight GL/GLX Laser SystemsIridex Corp · 2003
- Descendant · 3 generations on · 18 of its ownK062624 Next Generation LaserAlcon Laboratories · 2007
- Descendant · 4 generations on · 17 of its ownK101285 Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · Recalled
- Descendant · 5 generations on · 6 of its ownK121555 Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · Recalled
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K982031Oculight GL with the Dermatology HandpieceIridex Corp · 1998 · cites it directly22descendants
- K031665Iris Medical Oculight GL/GLX Laser SystemsIridex Corp · 2003 · 2 generations on21descendants
- K062624Next Generation LaserAlcon Laboratories · 2007 · 3 generations on18descendants
- K101285Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · 4 generations on17descendants
- K121555Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913569 | Compac a, Elite a, Elite a Plus, Surgica a | Hgm Medical Laser Systems, Inc. | 1991 | — |
| +1 | K982031 | Oculight GL with the Dermatology Handpiece | Iridex Corp | 1998 | — |
| +2 | K031665 | Iris Medical Oculight GL/GLX Laser Systems | Iridex Corp | 2003 | — |
| +3 | K062624 | Next Generation Laser | Alcon Laboratories | 2007 | — |
| +4 | K101285 | Constellation Vision System | Alcon Manufacturing, Ltd. | 2010 | 4 |
| +5 | K121555 | Centurion Vision System | Alcon Laboratories, Inc. | 2012 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (24)
See all 242 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 1, 2006 | Not classified | Z-0545-06 | Other | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K982031 (Iridex Corp, 1998) has gone furthest, with 22 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
https://510kreport.com/device/K913569 · printed Nov 6, 2026
Cite this page
510(k) Report. “K913569: Compac a, Elite a, Elite a Plus, Surgica a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913569
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026