510(k) · Cleared
ClearedGamp & Assoc. Disposable Endoocular Laser Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gamp & Assoc. · HQB Photocoagulator And Accessories
Cleared on Dec 22, 1995 after a 98-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 16 later devices descend from it.
- Decided
- Dec 22, 1995
- Review
- 98 days
- Class
- Class II
- Product code
- HQB
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 3 citing it directly.
- This deviceK954307 Gamp & Assoc. Disposable Endoocular Laser ProbeGamp & Assoc. · 1995
- Descendant · cites it directly · 11 of its ownK024061 Peregrine Straight Laser Probe, Model PD6000.00Peregrine Surgical, Ltd. · 2003
- Descendant · 2 generations on · 6 of its ownK031023 Peregrine Illuminating Laser Probe Model PD600.10Peregrine Surgical, Ltd. · 2003 · Recalled
- Descendant · 3 generations on · 4 of its ownK122997 23GA Curved Illuminating Laser ProbePeregrine Surgical, Ltd. · 2013
- Descendant · cites it directly · 3 of its ownK113857 Synergetics Directional Endoocular Laser ProbeSynergetics, Inc. · 2012
- Descendant · 4 generations on · 2 of its ownK151604 23ga Chandelier Illuminator, 25ga Chandelier IlluminatorPeregrine Surgical, Ltd. · 2015
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K024061Peregrine Straight Laser Probe, Model PD6000.00Peregrine Surgical, Ltd. · 2003 · cites it directly11descendants
- K031023Peregrine Illuminating Laser Probe Model PD600.10Peregrine Surgical, Ltd. · 2003 · 2 generations on6descendants
- K12299723GA Curved Illuminating Laser ProbePeregrine Surgical, Ltd. · 2013 · 3 generations on4descendants
- K113857Synergetics Directional Endoocular Laser ProbeSynergetics, Inc. · 2012 · cites it directly3descendants
- K15160423ga Chandelier Illuminator, 25ga Chandelier IlluminatorPeregrine Surgical, Ltd. · 2015 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954307 | Gamp & Assoc. Disposable Endoocular Laser Probe | Gamp & Assoc. | 1995 | — |
| +1 | K024061 | Peregrine Straight Laser Probe, Model PD6000.00 | Peregrine Surgical, Ltd. | 2003 | — |
| +2 | K031023 | Peregrine Illuminating Laser Probe Model PD600.10 | Peregrine Surgical, Ltd. | 2003 | 1 |
| +3 | K122997 | 23GA Curved Illuminating Laser Probe | Peregrine Surgical, Ltd. | 2013 | — |
| +1 | K113857 | Synergetics Directional Endoocular Laser Probe | Synergetics, Inc. | 2012 | — |
| +4 | K151604 | 23ga Chandelier Illuminator, 25ga Chandelier Illuminator | Peregrine Surgical, Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2019 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (16)
See all 163 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?
- Of its descendants, K024061 (Peregrine Surgical, Ltd., 2003) has gone furthest, with 11 descendants of its own.
How does its category compare?
All HQB devicesHQB Photocoagulator And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K954307 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954307: Gamp & Assoc. Disposable Endoocular Laser Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954307
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026