510(k) · Cleared
ClearedLION Photocoagulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Norlase Aps · HQF Laser, Ophthalmic
Cleared on Aug 11, 2020 as substantially equivalent to K190083 (Norlase Aps, 2019) and 1 other predicate after a 57-day review. Its family tree reaches back 8 generations to 1989. 1 later device descends from it.
- Decided
- Aug 11, 2020
- Review
- 57 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K894841 (1989). 24 ancestors in all, the oldest K812219 (1981). 1 later device descends 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 backK980547 Nidek Prima Model Gyc-1500/2000Nidek, Inc. · 1998
- 5 generations backK032085 Green Laser Photocoagulator Model Gyc-1000Nidek, Inc. · 2003 · Recalled
- 4 generations backK042785 Multi Color Laser Photocoagulator, Model MC-300Nidek, Inc. · 2004
- 3 generations backK110228 Nidek Multicolor Laser PhotocoagulatorNidek Incorporated · 2011 · Recalled
- 2 generations backK152603 Green Laser Photocoagulator GYC-500Nidek Co., Ltd. · 2016
- 1 generation backK190083 Leaf PhotocoagulatorNorlase Aps · 2019
- This deviceK201623 LION PhotocoagulatorNorlase Aps · 2020
- Descendant · cites it directly · 0 of its ownK251507 Integre LioQuantel Medical · 2026
Most influential descendants
Showing 1 of 1 · See all- K251507Integre LioQuantel Medical · 2026 · cites it directly0descendants
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 | K980547 | Nidek Prima Model Gyc-1500/2000 | Nidek, Inc. | 1998 | — |
| −5 | K032085 | Green Laser Photocoagulator Model Gyc-1000 | Nidek, Inc. | 2003 | 3 |
| −4 | K042785 | Multi Color Laser Photocoagulator, Model MC-300 | Nidek, Inc. | 2004 | — |
| −3 | K110228 | Nidek Multicolor Laser Photocoagulator | Nidek Incorporated | 2011 | 4 |
| −2 | K152603 | Green Laser Photocoagulator GYC-500 | Nidek Co., Ltd. | 2016 | — |
| −1 | K190083 | Leaf Photocoagulator | Norlase Aps | 2019 | — |
| 0 (this device) | K201623 | LION Photocoagulator | Norlase Aps | 2020 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K190083 | Leaf PhotocoagulatorSummary page 5….4390 (HQF) Classification Panel: Ophthalmology A. Legally Marketed Predicate Devices The primary predicate device is the Norlase LEAF Green Laser Photocoagulator (K190083). The reference predicate is the Iridex TruFocus LIO (K170718). B. Device Description: The Norlase Laser Indirect Ophthalmoscop… | 2019 |
| * | K170718 | Iridex TruFocus LIO PremiereSummary page 5…ly Marketed Predicate Devices The primary predicate device is the Norlase LEAF Green Laser Photocoagulator (K190083). The reference predicate is the Iridex TruFocus LIO (K170718). B. Device Description: The Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator system was developed to utilize advanc… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251507 | Integre Lio | 2026 | 0 |
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 31 years and passes through 5 companies; a new generation was cleared every 5.2 years on median.
- 3 of the 24 ancestors have a recall of any class.
- Of its descendants, K251507 (Quantel Medical, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K190083.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Norlase Laser Indirect Ophthalmoscope (LIO) Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201623: LION Photocoagulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201623
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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