510(k) · Cleared
ClearedIntegre Lio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantel Medical · HQF Laser, Ophthalmic
Cleared on Feb 6, 2026 as substantially equivalent to K201623 (Norlase Aps, 2020) after a 266-day review. Its family tree reaches back 9 generations to 1989.
- Decided
- Feb 6, 2026
- Review
- 266 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K894841 (1989). 25 ancestors in all, the oldest K812219 (1981). No later device cites it as a predicate yet.
- Root · 9 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 5 generations between
- 3 generations backK152603 Green Laser Photocoagulator GYC-500Nidek Co., Ltd. · 2016
- 2 generations backK190083 Leaf PhotocoagulatorNorlase Aps · 2019
- 1 generation backK201623 LION PhotocoagulatorNorlase Aps · 2020
- This deviceK251507 Integre LioQuantel Medical · 2026
Show all 9 generations
- Root · 9 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 8 generations backK960971 Oculight GLIriderm Div. · 1996
- 7 generations backK980547 Nidek Prima Model Gyc-1500/2000Nidek, Inc. · 1998
- 6 generations backK032085 Green Laser Photocoagulator Model Gyc-1000Nidek, Inc. · 2003 · Recalled
- 5 generations backK042785 Multi Color Laser Photocoagulator, Model MC-300Nidek, Inc. · 2004
- 4 generations backK110228 Nidek Multicolor Laser PhotocoagulatorNidek Incorporated · 2011 · Recalled
- 3 generations backK152603 Green Laser Photocoagulator GYC-500Nidek Co., Ltd. · 2016
- 2 generations backK190083 Leaf PhotocoagulatorNorlase Aps · 2019
- 1 generation backK201623 LION PhotocoagulatorNorlase Aps · 2020
- This deviceK251507 Integre LioQuantel Medical · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −8 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −7 | K980547 | Nidek Prima Model Gyc-1500/2000 | Nidek, Inc. | 1998 | — |
| −6 | K032085 | Green Laser Photocoagulator Model Gyc-1000 | Nidek, Inc. | 2003 | 3 |
| −5 | K042785 | Multi Color Laser Photocoagulator, Model MC-300 | Nidek, Inc. | 2004 | — |
| −4 | K110228 | Nidek Multicolor Laser Photocoagulator | Nidek Incorporated | 2011 | 4 |
| −3 | K152603 | Green Laser Photocoagulator GYC-500 | Nidek Co., Ltd. | 2016 | — |
| −2 | K190083 | Leaf Photocoagulator | Norlase Aps | 2019 | — |
| −1 | K201623 | LION Photocoagulator | Norlase Aps | 2020 | — |
| 0 (this device) | K251507 | Integre Lio | Quantel Medical | 2026 | — |
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 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 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 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? (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 |
|---|---|---|---|
| * | K201623 | LION PhotocoagulatorSummary page 5…laser Product Codes: HQF Device Classification Class II 21 C.F.R. §886.4390 Predicate Device(s) Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator cleared in K201623 K251507 2 Device… | 2020 |
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 37 years and passes through 6 companies; a new generation was cleared every 5.2 years on median.
- 3 of the 25 ancestors have a recall of any class.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 INTEGRE LIO is indicated to be used in ophthalmic laser procedures including retinal photocoagulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251507 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251507: Integre Lio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251507
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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