510(k) · Cleared
Cleared23GA Curved Illuminating Laser Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Peregrine Surgical, Ltd. · HQB Photocoagulator And Accessories
Cleared on Jun 26, 2013 as substantially equivalent to K031023 (Peregrine Surgical, Ltd., 2003) after a 272-day review. Its family tree reaches back 3 generations to 1995. 4 later devices descend from it.
- Decided
- Jun 26, 2013
- Review
- 272 days
- Class
- Class II
- Product code
- HQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K954307 (1995). 5 ancestors in all, the oldest K931784 (1994). 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK954307 Gamp & Assoc. Disposable Endoocular Laser ProbeGamp & Assoc. · 1995
- 2 generations backK024061 Peregrine Straight Laser Probe, Model PD6000.00Peregrine Surgical, Ltd. · 2003
- 1 generation backK031023 Peregrine Illuminating Laser Probe Model PD600.10Peregrine Surgical, Ltd. · 2003 · Recalled
- This deviceK122997 23GA Curved Illuminating Laser ProbePeregrine Surgical, Ltd. · 2013
- Descendant · cites it directly · 2 of its ownK151604 23ga Chandelier Illuminator, 25ga Chandelier IlluminatorPeregrine Surgical, Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK233653 Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga…Peregrine Surgical, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK182646 Vitreq disposable laser probes, light fibers and ChandelierVitreQ BV · 2019
- Descendant · cites it directly · 0 of its ownK133358 Nidek Multicolor Laser Photocoagulator System MC-500 Connected with…Nidek Co., Ltd. · 2014 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K15160423ga Chandelier Illuminator, 25ga Chandelier IlluminatorPeregrine Surgical, Ltd. · 2015 · cites it directly2descendants
- K233653Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00)…Peregrine Surgical, LLC · 2024 · 2 generations on0descendants
- K182646Vitreq disposable laser probes, light fibers and ChandelierVitreQ BV · 2019 · 2 generations on0descendants
- K133358Nidek Multicolor Laser Photocoagulator System MC-500 Connected with the…Nidek Co., Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954307 | Gamp & Assoc. Disposable Endoocular Laser Probe | Gamp & Assoc. | 1995 | — |
| −2 | K024061 | Peregrine Straight Laser Probe, Model PD6000.00 | Peregrine Surgical, Ltd. | 2003 | — |
| −1 | K031023 | Peregrine Illuminating Laser Probe Model PD600.10 | Peregrine Surgical, Ltd. | 2003 | 1 |
| 0 (this device) | K122997 | 23GA Curved Illuminating Laser Probe | Peregrine Surgical, Ltd. | 2013 | — |
| +1 | K151604 | 23ga Chandelier Illuminator, 25ga Chandelier Illuminator | Peregrine Surgical, Ltd. | 2015 | — |
| +2 | K233653 | Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga… | Peregrine Surgical, LLC | 2024 | — |
| +2 | K182646 | Vitreq disposable laser probes, light fibers and Chandelier | VitreQ BV | 2019 | — |
| +1 | 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 |
|---|---|---|
| 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 HQB? 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 HQB device
- #1 K220263 Vortex Surgical Laser Probes, Vortex Surgical…score 3.8 · 6 generations · no Class I recall
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 |
|---|---|---|---|
| * | K031023 | Peregrine Illuminating Laser Probe Model PD600.10Summary page 2…redicate device ** Substantial Equivalence Comparison: The 23ga Curved Illuminating Laser Probe is equivalent to Peregrine’s [lluminated Laser Probe (PD600.10 — 510(k) #K031023) except for the curved nitinol needle, the smaller glass laser fiber, the smaller acrylic illumination fiber, the jacket color an… | 2003 |
| † | K062624 | Next Generation Laser | 2007 |
| † | K101325 | Stellaris PC Vision Enhancement System | 2010 |
What descends from it? (4)
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 18 years and passes through 2 companies; a new generation was cleared every 7.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K151604 (Peregrine Surgical, Ltd., 2015) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K031023.
How does its category compare?
All HQB devicesHQB Photocoagulator And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · HQB
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · HQB
221in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQB
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQB
7in 2025
MAUDE reports naming product code HQB, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 3 | 57 | 0 | 3 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 3 | 221 | 28 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 2 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 2 | 7 |
| 2026 | 0 | — | 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K122997 · printed Nov 4, 2026
Cite this page
510(k) Report. “K122997: 23GA Curved Illuminating Laser Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122997
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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