510(k) · Cleared
Recalled · Class II · 2014Scanning Laserlink
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis, Inc. · HQF Laser, Ophthalmic
Cleared on Nov 1, 2013 as substantially equivalent to K111493 (Nidek Co., Ltd., 2011) and 3 other predicates after a 277-day review. Its family tree reaches back 8 generations to 1989. It has been recalled once.
- Decided
- Nov 1, 2013
- Review
- 277 days
- Class
- Class II
- Product code
- HQF
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 8 generations to K894841 (1989). 29 ancestors in all, the oldest K812219 (1981). No later device cites it as a predicate yet.
- 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 deviceK130195 Scanning LaserlinkLumenis, Inc. · 2013
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) | K130195 | Scanning Laserlink | Lumenis, Inc. | 2013 | — |
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 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 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 HQF? 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 HQF device
- #1 K251772 Navilas Laser System 577sl (156691)score 13.6 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K111493 | Nidek Multicolor Scan Laser Photocoagulator MC-500 VixiSummary page 1…ate Device Namne(s): Trade Name(s): Nidek Multicolor Scan Laser Photocoagulator MC-500 Vixi (#KI 111493). Topcon PASCAL Streamline 577 (#K I 11108),… | 2011 |
| * | K111108 | Pascal Streamline 577 (with Accessories)Summary page 3…identified predicate device - Nidek Multicolor Scan Laser Photocoagulator MC- 500 Vixi (#KI 111493), Topcon PASCAL Streamline 577 (#KI 111108), Topcon (OptiMedica) PASCAL Streamline Photocoagulator (#KIOOOIQ); and Lumenis Vision One… | 2011 |
| * | K100019 | Pascal Streamline PhotocoagulatorSummary page 3…Predicate Predicate Predicate Device Predicate Device Subject Device Device Device K100019 KlI1108 Topcon Topcon /OptiMedica KI 1… | 2010 |
| * | K111213 | Vision One Laser SystemSummary page 4…K 100019 KI 11108 Topcon Topcon /OptiMedica K1 11213 K(130195 K(111493 PASCAL PASCAL Lumenis Vision Lume… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 15, 2014 | Class II | Z-2733-2014 | Software design | Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) because the system may project an erroneous pattern display on the retina, which is different than the desired pattern. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 29 ancestors have a recall of any class.
- 2 other devices also cite its predicate K111493.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · HQF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQF
264in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQF
106in 2025
MAUDE reports naming product code HQF, 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 | 4 | 198 | 2 | 60 |
| 2008 | 3 | 28 | 1 | 34 |
| 2009 | 7 | 115 | 2 | 33 |
| 2010 | 2 | — | 3 | 43 |
| 2011 | 4 | 128 | 5 | 26 |
| 2012 | 5 | 179 | 1 | 41 |
| 2013 | 6 | 225 | 2 | 39 |
| 2014 | 3 | 215 | 4 | 58 |
| 2015 | 4 | 295 | 0 | 80 |
| 2016 | 3 | 271 | 0 | 108 |
| 2017 | 3 | 189 | 0 | 77 |
| 2018 | 1 | — | 0 | 82 |
| 2019 | 4 | 107 | 0 | 66 |
| 2020 | 4 | 53 | 0 | 72 |
| 2021 | 1 | — | 0 | 100 |
| 2022 | 7 | 86 | 0 | 111 |
| 2023 | 5 | 155 | 0 | 92 |
| 2024 | 3 | 167 | 0 | 75 |
| 2025 | 3 | 264 | 1 | 106 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Lumenis® Array Tm LaserLink TM device is a laser system accessory intended for use in the treatment of ocular pathology. "For the posterior segment, the Lumenis® Array"rm LaserL-ink TM device is indicated for use in-retinal photocoagulation and panretinal photocoagulation of vascular and structural abnormalities of the retina and choroid including: o Proliferative and severe and very severe nonproliferative diabetic retinopathy o Macular edema…
Read the full statement (161 words)
The Lumenis® Array Tm LaserLink TM device is a laser system accessory intended for
use in the treatment of ocular pathology.
"For the posterior segment, the Lumenis® Array"rm LaserL-ink TM device is
indicated for use in-retinal photocoagulation and panretinal photocoagulation of
vascular and structural abnormalities of the retina and choroid including:
o Proliferative and severe and very severe nonproliferative diabetic
retinopathy
o Macular edema associated with proliferative or nonproliferative diabetic
retinopathy
o Choroidal neovascularization
o Retinal neovascularization associated with retinal occlusive disease
(Branch retinal vein occlusion; Central retinal vein occlusion) -
o Macular edema associated with Branch retinal vein occlusion
o Retinal tears and detachments
* And anterior segments as follows:
o Iridotomy in closed angle glaucoma
o Trabeculoplasty in open angle glaucoma
The Lumenis Laser Systems compatible for connection with the Lumenis® Array
LaserL-ink TM device are:
* Novus Spectra~"' Laser System (K022327)(532nm)
" Novus Spectra Dual Port Laser System (K022327)(532nm)
* Vision One" ' Laser System (K111213)(532nm, 577nm, 659nm)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130195 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130195: Scanning Laserlink.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130195
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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