510(k) · Cleared
ClearedTxcell Scanning Laser Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iridex Corp · GEX Powered Laser Surgical Instrument
Cleared on Nov 28, 2012 as substantially equivalent to K071687 (Iridex Corp, 2008) and 2 other predicates after a 194-day review. Its family tree reaches back 8 generations to 1989. 6 later devices descend from it.
- Decided
- Nov 28, 2012
- Review
- 194 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K894841 (1989). 29 ancestors in all, the oldest K812219 (1981). 6 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 7 generations backK960971 Oculight GLIriderm Div. · 1996
- 6 generations backK020374 Oculight SL/SLXIridex Corp · 2002
- 5 generations backK043486 Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc. · 2005
- 4 generations backK091666 Pascal Photocoagulator, Pascal-USOptimedica Corporation · 2009
- 3 generations backK092621 Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc. · 2009
- 2 generations backK100019 Pascal Streamline PhotocoagulatorOptimedica Corporation · 2010 · Recalled
- 1 generation backK111108 Pascal Streamline 577 (with Accessories)Topcon Medical Laser Systems, Inc. · 2011
- This deviceK121475 Txcell Scanning Laser Delivery SystemIridex Corp · 2012
- Descendant · cites it directly · 5 of its ownK123542 Pascal Synthesis (532NM/577NM) Opthalmic LaserTopcon Medical Laser Systems, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 2 of its ownK141851 Navilas Laser SystemOd-Os GmbH · 2015
- Descendant · 2 generations on · 1 of its ownK223132 Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and…Iridex Corporation · 2022
- Descendant · 3 generations on · 1 of its ownK162191 NAVILAS Laser SystemOd-Os GmbH · 2016
- Descendant · 3 generations on · 0 of its ownK251772 Navilas Laser System 577sl (156691)Od-Os GmbH · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K123542Pascal Synthesis (532NM/577NM) Opthalmic LaserTopcon Medical Laser Systems, Inc. · 2013 · cites it directly5descendants
- K141851Navilas Laser SystemOd-Os GmbH · 2015 · 2 generations on2descendants
- K223132Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)Iridex Corporation · 2022 · 2 generations on1descendant
- K162191NAVILAS Laser SystemOd-Os GmbH · 2016 · 3 generations on1descendant
- K251772Navilas Laser System 577sl (156691)Od-Os GmbH · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −7 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −6 | K020374 | Oculight SL/SLX | Iridex Corp | 2002 | — |
| −5 | K043486 | Pascal Photocoagulator, Product-Pascal-01 | Topcon Medical Laser Systems, Inc. | 2005 | — |
| −4 | K091666 | Pascal Photocoagulator, Pascal-US | Optimedica Corporation | 2009 | — |
| −3 | K092621 | Pascal Streamline Photocoagulator | Topcon Medical Laser Systems, Inc. | 2009 | — |
| −2 | K100019 | Pascal Streamline Photocoagulator | Optimedica Corporation | 2010 | 1 |
| −1 | K111108 | Pascal Streamline 577 (with Accessories) | Topcon Medical Laser Systems, Inc. | 2011 | — |
| 0 (this device) | K121475 | Txcell Scanning Laser Delivery System | Iridex Corp | 2012 | — |
| +1 | K123542 | Pascal Synthesis (532NM/577NM) Opthalmic Laser | Topcon Medical Laser Systems, Inc. | 2013 | 1 |
| +2 | K141851 | Navilas Laser System | Od-Os GmbH | 2015 | — |
| +2 | K223132 | Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) | Iridex Corporation | 2022 | — |
| +3 | K162191 | NAVILAS Laser System | Od-Os GmbH | 2016 | — |
| +3 | K251772 | Navilas Laser System 577sl (156691) | Od-Os GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K071687 | Famili of Iridex IQ Laser SystemsSummary page 2…1 TxCeII Scanning Laser Delivery System H. Predicate Devices: Family of IRIDEX IQ Laser Systems (IQ 532, IQ 577, IQ 630-670, IQ 810) (K071687) Quantel SUPRA SCANTh Delivery System (K 100678) Topcon PASCAL Streamline 577 (K1 11108) I. Produ… | 2008 |
| * | K100678 | Supra Scan Delivery SystemSummary page 2…. Predicate Devices: Family of IRIDEX IQ Laser Systems (IQ 532, IQ 577, IQ 630-670, IQ 810) (K071687) Quantel SUPRA SCANTh Delivery System (K 100678) Topcon PASCAL Streamline 577 (K1 11108) I. Product Description: The TxCellTh Scanning Laser Del… | 2010 |
| * | K111108 | Pascal Streamline 577 (with Accessories)Summary page 2…RIDEX IQ Laser Systems (IQ 532, IQ 577, IQ 630-670, IQ 810) (K071687) Quantel SUPRA SCANTh Delivery System (K 100678) Topcon PASCAL Streamline 577 (K1 11108) I. Product Description: The TxCellTh Scanning Laser Delivery System is a slit lamp adapter laser… | 2011 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123542 | Pascal Synthesis (532NM/577NM) Opthalmic Laser | 2013 | 5 |
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 23 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 29 ancestors has a recall of any class.
- Of its descendants, K123542 (Topcon Medical Laser Systems, Inc., 2013) has gone furthest, with 5 descendants of its own.
- 12 other devices also cite its predicate K071687.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
When the TxCell Scanning Laser Delivery System is connected to the 1Q0532 (532 nm), the 10 577 (577 nm) or the IQ0810 (810 nm) Laser Console, from the IRIDEX Family of IQ Laser Systems and used to deliver laser energy in CW-Pulse, MicroPulse or LongPulse mode, it is intended to be used by a trained ophthalmologist for the treatment of ocular pathology of both the anterior and posterior segments of the eye. 532 nm Indicated for retinal photocoagulation…
Read the full statement (283 words)
When the TxCell Scanning Laser Delivery System is connected to the 1Q0532 (532 nm), the 10 577 (577 nm) or the IQ0810 (810 nm) Laser Console, from the IRIDEX Family of IQ Laser Systems and used to deliver laser energy in CW-Pulse, MicroPulse or LongPulse mode, it is intended to be used by a trained ophthalmologist for the treatment of ocular pathology of both the anterior and posterior segments of the eye.
532 nm
Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty including:
Retinal photocoagulation (RPC) for the treatment of:
Diabetic retinopathy, including:
Nonproliferative retinopathy
Macular edema
Proliferative retinopathy
Retinal tears and detachments
Lattice degeneration
Age-related macular degeneration (AMD) with choroidal neovascularization (CNV)
Sub-retinal (choroidal) neovascularization
Central and branch retinal vein occlusion
Laser trabeculoplasty for the treatment of:
Primary open angle glaucoma
Laser iridotomy, iridoplasty for the treatment of:
Angle closure glaucoma
577 nm
Indicated for use in photocoagulation of both anterior and posterior segments including:
Retinal photocoagulation, panretinal photocoagulation of vascular and structure abnormalities of the retina and choroid including:
Proliferative and nonproliferative diabetic retinopathy
Choroidal neovascularization
Branch retinal vein occlusion
Age-related macular degeneration (AMD) with choroidal neovascularization (CNV)
Retinal tears and detachments
Laser trabeculoplasty for the treatment of:
Primary open angle glaucoma
Laser iridotomy, iridoplasty for the treatment of:
Angle closure glaucoma
810 nm
Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy including:
Retinal photocoagulation for the treatment of:
Diabetic retinopathy, including:
Nonproliferative retinopathy
Macular edema
Proliferative retinopathy
Retinal tears, detachments and hole
Lattice degeneration
Age-related macular degeneration (AMD) with choroidal neovascularization (CNV)
Sub-retinal (choroidal) neovascularization
Central and branch retinal vein occlusion
Laser trabeculoplasty for the treatment of:
Primary open angle glaucoma
Laser iridotomy, iridoplasty for the treatment of:
Angle closure glaucoma
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121475 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121475: Txcell Scanning Laser Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121475
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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