510(k) · Cleared
ClearedLeaf 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 May 3, 2019 as substantially equivalent to K152603 (Nidek Co., Ltd., 2016) after a 106-day review. Its family tree reaches back 7 generations to 1989. 3 later devices descend from it.
- Decided
- May 3, 2019
- Review
- 106 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K894841 (1989). 21 ancestors in all, the oldest K812219 (1981). 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 6 generations backK960971 Oculight GLIriderm Div. · 1996
- 5 generations backK980547 Nidek Prima Model Gyc-1500/2000Nidek, Inc. · 1998
- 4 generations backK032085 Green Laser Photocoagulator Model Gyc-1000Nidek, Inc. · 2003 · Recalled
- 3 generations backK042785 Multi Color Laser Photocoagulator, Model MC-300Nidek, Inc. · 2004
- 2 generations backK110228 Nidek Multicolor Laser PhotocoagulatorNidek Incorporated · 2011 · Recalled
- 1 generation backK152603 Green Laser Photocoagulator GYC-500Nidek Co., Ltd. · 2016
- This deviceK190083 Leaf PhotocoagulatorNorlase Aps · 2019
- Descendant · cites it directly · 1 of its ownK201623 LION PhotocoagulatorNorlase Aps · 2020
- Descendant · 2 generations on · 0 of its ownK251507 Integre LioQuantel Medical · 2026
- Descendant · cites it directly · 0 of its ownK222157 ECHO PhotocoagulatorNorlase · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −6 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −5 | K980547 | Nidek Prima Model Gyc-1500/2000 | Nidek, Inc. | 1998 | — |
| −4 | K032085 | Green Laser Photocoagulator Model Gyc-1000 | Nidek, Inc. | 2003 | 3 |
| −3 | K042785 | Multi Color Laser Photocoagulator, Model MC-300 | Nidek, Inc. | 2004 | — |
| −2 | K110228 | Nidek Multicolor Laser Photocoagulator | Nidek Incorporated | 2011 | 4 |
| −1 | K152603 | Green Laser Photocoagulator GYC-500 | Nidek Co., Ltd. | 2016 | — |
| 0 (this device) | K190083 | Leaf Photocoagulator | Norlase Aps | 2019 | — |
| +1 | K201623 | LION Photocoagulator | Norlase Aps | 2020 | — |
| +2 | K251507 | Integre Lio | Quantel Medical | 2026 | — |
| +1 | K222157 | ECHO Photocoagulator | Norlase | 2022 | — |
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 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K152603 | Green Laser Photocoagulator GYC-500Summary page 4…(HQF) Classification Panel: Ophthalmology A. Legally Marketed Predicate Devices The predicate device is the NIDEK Green Laser Photocoagulator GYC-500 (“NIDEK”). (K152603) B. Device Description: The Norlase Leaf device consists of a laser unit, a wireless control unit and a foot switch. The laser… | 2016 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 30 years and passes through 5 companies; a new generation was cleared every 5.2 years on median.
- 2 of the 21 ancestors have a recall of any class.
- Of its descendants, K201623 (Norlase Aps, 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K152603.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Leaf Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190083 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190083: Leaf Photocoagulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190083
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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