510(k) · Cleared
ClearedSmart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Feb 28, 2017 as substantially equivalent to K022181 (Lumenis, Inc., 2002) after a 140-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Feb 28, 2017
- Review
- 140 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K894841 (1989). 12 ancestors in all, the oldest K812219 (1981). No later device cites it as a predicate yet.
- 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 deviceK162837 Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for…Lumenis, Ltd. · 2017
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) | K162837 | Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis… | Lumenis, Ltd. | 2017 | — |
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 |
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 4…21 CFR 878.4810 Panel: General & Plastic Surgery Predicate Device: Laser Indirect Ophthalmoscope, Keeler model, cleared under K022181. Reference Devices: Keeler Vantage Plus Binocular Indirect Ophthalmoscope cleared under K… | 2002 |
| † | K060822 | Vantage Indirect Ophthalmoscope | 2006 |
| † | K151109 | Lumenis Smart532 Laser System | 2015 |
| † | K111213 | Vision One Laser System | 2011 |
| † | K022327 | Novus Spectra | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- None of the 12 ancestors has a recall.
- 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. 2017, 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 Lumenis Smart Laser Indirect Ophthalmoscope (LIO) is a battery-powered optical instrument intended for the viewing of the posterior segment of the eye and to deliver laser energy for photocoagulation procedures on the peripheral retina of the eye (in conjunction with the use of a hand-held condensing lens). The Smart LIO is indicated for use in the following photocoagulation procedures: - Panretinal photocoagulation; - Segmental peripheral…
Read the full statement (114 words)
The Lumenis Smart Laser Indirect Ophthalmoscope (LIO) is a battery-powered optical instrument intended for the viewing of the posterior segment of the eye and to deliver laser energy for photocoagulation procedures on the peripheral retina of the eye (in conjunction with the use of a hand-held condensing lens).
The Smart LIO is indicated for use in the following photocoagulation procedures:
- Panretinal photocoagulation;
- Segmental peripheral photocoagulation;
- Retinopexy; and,
- Pediatric retinal repairs (under general anesthesia).
The Smart LIO is intended to work in conjunction with the following Lumenis laser systems in ophthalmic photocoagulation procedures:
- Lumenis Novus Spectra Laser System;
- Lumenis Vision One Laser System; and
- Lumenis Smart532™ Laser System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162837 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162837: Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ 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/K162837
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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