510(k) · Cleared
Recalled · Class II · 2021Peregrine Illuminating Laser Probe Model PD600.10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Peregrine Surgical, Ltd. · HQF Laser, Ophthalmic
Cleared on Jun 27, 2003 as substantially equivalent to K024061 (Peregrine Surgical, Ltd., 2003) and 1 other predicate after an 88-day review. Its family tree reaches back 2 generations to 1995. 6 later devices descend from it. It has been recalled once.
- Decided
- Jun 27, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- HQF
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K954307 (1995). 4 ancestors in all, the oldest K931784 (1994). 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK954307 Gamp & Assoc. Disposable Endoocular Laser ProbeGamp & Assoc. · 1995
- 1 generation backK024061 Peregrine Straight Laser Probe, Model PD6000.00Peregrine Surgical, Ltd. · 2003
- This deviceK031023 Peregrine Illuminating Laser Probe Model PD600.10Peregrine Surgical, Ltd. · 2003
- Descendant · cites it directly · 4 of its ownK122997 23GA Curved Illuminating Laser ProbePeregrine Surgical, Ltd. · 2013
- Descendant · 2 generations on · 2 of its ownK151604 23ga Chandelier Illuminator, 25ga Chandelier IlluminatorPeregrine Surgical, Ltd. · 2015
- Descendant · 3 generations on · 0 of its ownK233653 Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga…Peregrine Surgical, LLC · 2024
- Descendant · 3 generations on · 0 of its ownK182646 Vitreq disposable laser probes, light fibers and ChandelierVitreQ BV · 2019
- Descendant · 2 generations on · 0 of its ownK133358 Nidek Multicolor Laser Photocoagulator System MC-500 Connected with…Nidek Co., Ltd. · 2014 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K12299723GA Curved Illuminating Laser ProbePeregrine Surgical, Ltd. · 2013 · cites it directly4descendants
- K15160423ga Chandelier Illuminator, 25ga Chandelier IlluminatorPeregrine Surgical, Ltd. · 2015 · 2 generations on2descendants
- K233653Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00)…Peregrine Surgical, LLC · 2024 · 3 generations on0descendants
- K182646Vitreq disposable laser probes, light fibers and ChandelierVitreQ BV · 2019 · 3 generations on0descendants
- K133358Nidek Multicolor Laser Photocoagulator System MC-500 Connected with the…Nidek Co., Ltd. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954307 | Gamp & Assoc. Disposable Endoocular Laser Probe | Gamp & Assoc. | 1995 | — |
| −1 | K024061 | Peregrine Straight Laser Probe, Model PD6000.00 | Peregrine Surgical, Ltd. | 2003 | — |
| 0 (this device) | K031023 | Peregrine Illuminating Laser Probe Model PD600.10 | Peregrine Surgical, Ltd. | 2003 | — |
| +1 | K122997 | 23GA Curved Illuminating Laser Probe | Peregrine Surgical, Ltd. | 2013 | — |
| +2 | K151604 | 23ga Chandelier Illuminator, 25ga Chandelier Illuminator | Peregrine Surgical, Ltd. | 2015 | — |
| +3 | K233653 | Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga… | Peregrine Surgical, LLC | 2024 | — |
| +3 | K182646 | Vitreq disposable laser probes, light fibers and Chandelier | VitreQ BV | 2019 | — |
| +2 | K133358 | Nidek Multicolor Laser Photocoagulator System MC-500 Connected with the… | Nidek Co., Ltd. | 2014 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K024061 | Peregrine Straight Laser Probe, Model PD6000.00 | 2003 |
| * | K931784 | HGM Illuminating Imaging Endocular ProbeSummary page 2…Application for 510K Product PD600.00 HGM Illuminating Laser Probe Peregrine Illuminated KO24061 510K K931784 Laser Probe Peregrine Straight Laser Probe Manufactured by Garnp & Assoc. Manufactured by Peregrine… | 1994 |
What descends from it? (6)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 14, 2021 | Class II | Z-2097-2021 | Process control | Barcode label extended expiration date. Barcode located at the short side of the outer box shows 2025-10-27 when scanned, while the correct expiry date is 2024-10-01 |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 7.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K122997 (Peregrine Surgical, Ltd., 2013) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K024061.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
For photocoagulation and illumination during ophthalmic surgery. This device delivers illumination as well as laser energy to target tissue, causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031023 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031023: Peregrine Illuminating Laser Probe Model PD600.10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031023
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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