510(k) · Cleared
Recalled · Class II · 2013Vision One Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jul 25, 2011 as substantially equivalent to K022181 (Lumenis, Inc., 2002) after an 84-day review. Its family tree reaches back 3 generations to 1989. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 25, 2011
- Review
- 84 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K894841 (1989). 12 ancestors in all, the oldest K812219 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 2 generations backK960971 Oculight GLIriderm Div. · 1996
- 1 generation backK022181 Novus Varia Ophthalmic Laser and Delivery Devices with AccessoriesLumenis, Inc. · 2002
- This deviceK111213 Vision One Laser SystemLumenis, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK130195 Scanning LaserlinkLumenis, Inc. · 2013 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K130195Scanning LaserlinkLumenis, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −2 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −1 | K022181 | Novus Varia Ophthalmic Laser and Delivery Devices with Accessories | Lumenis, Inc. | 2002 | — |
| 0 (this device) | K111213 | Vision One Laser System | Lumenis, Inc. | 2011 | — |
| +1 | K130195 | Scanning Laserlink | Lumenis, Inc. | 2013 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022181 | Novus Varia Ophthalmic Laser and Delivery Devices with AccessoriesSummary page 1…21 CFR § 886.4390, Ophthalmic Laser Ill. Predicate Device Name(s): Trade Name(s): Novus Varia Laser System (K022181) IV. Device Description: The Vision One Laser System is classified as a Class IV laser by the Center for… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130195 | Scanning Laserlink | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 19, 2013 | Class II | Z-2191-2013 | Software design | Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K130195 (Lumenis, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 13 other devices also cite its predicate K022181.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Vision One Laser System is intended for use in the treatment of ocular pathology. The Vision One Laser System green, yellow, and red wavelengths are indicated for use in photocoagulation of both anterior and posterior segments including:
Retinal photocoagulation, panretinal. photocoagulation, and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
Proliferative and nonproliferative diabetic retinopathy
Choroidal. neovascultarization
Branch retinal, vein occlusion
Retinal tears and detachments
Retinopathy of prematurity
Iridlotomy, iridectomy, and trabeculoplasty in angle closure glaucoma and open angle glaucoma
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111213: Vision One Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111213
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026