510(k) · Cleared
ClearedLumenis 1000 Integrated Slit Lamp
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 Aug 30, 2005 as substantially equivalent to K022181 (Lumenis, Inc., 2002) and 4 other predicates after a 25-day review. Its family tree reaches back 3 generations to 1989. 5 later devices descend from it.
- Decided
- Aug 30, 2005
- Review
- 25 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K894841 (1989). 15 ancestors in all, the oldest K812219 (1981). 5 later devices descend 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 deviceK052129 Lumenis 1000 Integrated Slit LampLumenis, Inc. · 2005
- Descendant · cites it directly · 4 of its ownK052526 Novus 3000 Laser System and Delivery DevicesLumenis, Inc. · 2005
- Descendant · 2 generations on · 1 of its ownK062336 Optimedica Laser Indirect OphthalmoscopeOptimedica Corporation · 2006
- Descendant · 2 generations on · 1 of its ownK061025 Accutech Endolite ProbeAccutech Medical Technologies, Inc. · 2006
- Descendant · 3 generations on · 0 of its ownK123056 Pascal Laser Indirect OphthalmoscopeTopcon Medical Laser Systems, Inc. (Tmls) · 2012
- Descendant · 3 generations on · 0 of its ownK090281 Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc. · 2009
Most influential descendants
Showing 5 of 5 · See all- K052526Novus 3000 Laser System and Delivery DevicesLumenis, Inc. · 2005 · cites it directly4descendants
- K062336Optimedica Laser Indirect OphthalmoscopeOptimedica Corporation · 2006 · 2 generations on1descendant
- K061025Accutech Endolite ProbeAccutech Medical Technologies, Inc. · 2006 · 2 generations on1descendant
- K123056Pascal Laser Indirect OphthalmoscopeTopcon Medical Laser Systems, Inc. (Tmls) · 2012 · 3 generations on0descendants
- K090281Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc. · 2009 · 3 generations on0descendants
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) | K052129 | Lumenis 1000 Integrated Slit Lamp | Lumenis, Inc. | 2005 | — |
| +1 | K052526 | Novus 3000 Laser System and Delivery Devices | Lumenis, Inc. | 2005 | — |
| +2 | K062336 | Optimedica Laser Indirect Ophthalmoscope | Optimedica Corporation | 2006 | — |
| +2 | K061025 | Accutech Endolite Probe | Accutech Medical Technologies, Inc. | 2006 | — |
| +3 | K123056 | Pascal Laser Indirect Ophthalmoscope | Topcon Medical Laser Systems, Inc. (Tmls) | 2012 | — |
| +3 | K090281 | Accutech Family of Powerflex Laser Delivery Devices | Accutech Medical Technologies, Inc. | 2009 | — |
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 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 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? (5)
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…GEX, Laser powered surgical instrument III. Predicate Devices Lurnenis (Coherent) LaserLink Z- 1000 Slit Lamp Laser Delivery Adapter [K022 181, K022327, K000498] Lumenis (HOM) Ml140 Integrated Slit Lamp (K9901 74, K022327, K98 1952) IV. Produc… | 2002 |
| * | K022327 | Novus SpectraSummary page 1…X, Laser powered surgical instrument III. Predicate Devices Lurnenis (Coherent) LaserLink Z- 1000 Slit Lamp Laser Delivery Adapter [K022 181, K022327, K000498] Lumenis (HOM) Ml140 Integrated Slit Lamp (K9901 74, K022327, K98 1952) IV. Product Description… | 2002 |
| * | K000498 | Coherent Laserlink Z-1000 Slit Lamp Laser Delivery AdapterSummary page 1…powered surgical instrument III. Predicate Devices Lurnenis (Coherent) LaserLink Z- 1000 Slit Lamp Laser Delivery Adapter [K022 181, K022327, K000498] Lumenis (HOM) Ml140 Integrated Slit Lamp (K9901 74, K022327, K98 1952) IV. Product Description Th… | 2000 |
| * | K990174 | Atlas-Elite,Model E-80,Corium 200,Corium 400, Model E-90, Elite, Model E-80-II, Elite…Summary page 1…Lurnenis (Coherent) LaserLink Z- 1000 Slit Lamp Laser Delivery Adapter [K022 181, K022327, K000498] Lumenis (HOM) Ml140 Integrated Slit Lamp (K9901 74, K022327, K98 1952) IV. Product Description The Lumenis 1000 Integrated Slit Lamp consists of an ophthalmic l… | 1999 |
| * | K981952 | Combination ND:Yag and Frequency Doubled Solid State Green LaserSummary page 1…herent) LaserLink Z- 1000 Slit Lamp Laser Delivery Adapter [K022 181, K022327, K000498] Lumenis (HOM) Ml140 Integrated Slit Lamp (K9901 74, K022327, K98 1952) IV. Product Description The Lumenis 1000 Integrated Slit Lamp consists of an ophthalmic laser delivery syste… | 1998 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052526 | Novus 3000 Laser System and Delivery Devices | 2005 | 4 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 6.1 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K052526 (Lumenis, Inc., 2005) has gone furthest, with 4 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.
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 Lumenis 1000 Integrated Slit Lamp laser delivery system is indicated for a variety of ophthalmic diagnostic and treatment uses including, but not limited to, the indications specified in the compatible laser's Operator Manuals. The Lumenis 1000 Integrated Slit Lamp may be used in the medical specialties or procedures that have been given market clearance by the Food and Drug Administration through the compatible laser systems. The Lumenis 1000 Integrated Slit Lamp is compatible with Lumenis lasers only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052129 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052129: Lumenis 1000 Integrated Slit Lamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052129
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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