510(k) Report

510(k) · Cleared

Cleared

Peregrine Soft Tip Aspirating Laser Probe, Model PD720.60

K061024510(k) TraditionalCleared Jun 21, 200669-day reviewClass II21 CFR 886.4390

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Peregrine Surgical, Ltd. · HQF Laser, Ophthalmic

Cleared on Jun 21, 2006 as substantially equivalent to K954308 (Gamp & Assoc., 1995) and 1 other predicate after a 69-day review. Its family tree reaches back 1 generation to 1995.

Decided
Jun 21, 2006
Review
69 days
Class
Class II
Product code
HQF
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K946135 (1995). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 1 other ancestorK946135 · Infinitech Aspirating Laser Probe · Surgical Technologies, Inc. · 19951996199820002002200420062008
Other ancestors, by generation 1 generation back: 1 other ancestor K946135 · Infinitech Aspirating Laser Probe · Surgical Technologies, Inc. · 19950
  1. Root · 1 generation backK946135 Infinitech Aspirating Laser ProbeSurgical Technologies, Inc. · 1995
  2. This deviceK061024 Peregrine Soft Tip Aspirating Laser Probe, Model PD720.60Peregrine Surgical, Ltd. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K946135Infinitech Aspirating Laser ProbeSurgical Technologies, Inc.1995—
0 (this device)K061024Peregrine Soft Tip Aspirating Laser Probe, Model PD720.60Peregrine Surgical, Ltd.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
FIG. 1 — Lineage of K061024, 1995–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251772 Navilas Laser System 577sl (156691)score 13.6 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K954308Gamp & Assoc. Disposable Aspirating Endoocular Laser Probe
Summary page 2
…stantial Equivalence to: Product PD720.60 Aspirating Laser Probe Infinitech Aspirating Laser Probe Peregrine Soft Tip Aspirating 510K K954308 510K K946135 Laser Probe Manufactured by Gamp & Assoc. Manufactured by Infinitech Li…
Gamp & Assoc.1995—
*K946135Infinitech Aspirating Laser Probe
Summary page 2
…duct PD720.60 Aspirating Laser Probe Infinitech Aspirating Laser Probe Peregrine Soft Tip Aspirating 510K K954308 510K K946135 Laser Probe Manufactured by Gamp & Assoc. Manufactured by Infinitech Light transmission for…
Surgical Technologies, Inc.1995—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • None of the 2 ancestors has a recall.

How does its category compare?

All HQF devices

HQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HQF

3in 2025

2007: 42008: 32009: 72010: 22011: 42012: 52013: 62014: 32015: 42016: 32017: 32018: 12019: 42020: 42021: 12022: 72023: 52024: 32025: 32026 (partial year): 2
2007high 7 (2009) · low 1 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HQF

264in 2025

2007: 198 days median2008: 28 days median2009: 115 days median2011: 128 days median2012: 179 days median2013: 225 days median2014: 215 days median2015: 295 days median2016: 271 days median2017: 189 days median2019: 107 days median2020: 53 days median2022: 86 days median2023: 155 days median2024: 167 days median2025: 264 days median
2007high 295 (2015) · low 28 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HQF

1in 2025

2007: 22008: 12009: 22010: 32011: 52012: 12013: 22014: 42025: 1
2007high 5 (2011) · low 0 (2015)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HQF

106in 2025

2007: 602008: 342009: 332010: 432011: 262012: 412013: 392014: 582015: 802016: 1082017: 772018: 822019: 662020: 722021: 1002022: 1112023: 922024: 752025: 106
2007high 111 (2022) · low 26 (2011)2025

MAUDE reports naming product code HQF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074198260
2008328134
20097115233
20102—343
20114128526
20125179141
20136225239
20143215458
20154295080
201632710108
20173189077
20181—082
20194107066
2020453072
20211—0100
20227860111
20235155092
20243167075
202532641106
20262—0—

What is it indicated for?

For use during ophthalmic surgery for photocoagulation and

aspiration in conjunction with Coherent/Alcon laser and aspiration units. Laser

wavelengths range from 193nm to 633nm.

Indications for use as stated in the FDA summary.

More from Peregrine Surgical, Ltd.

19 FDA decisions under this applicant name. See the company

  • K15160423ga Chandelier Illuminator, 25ga Chandelier IlluminatorPeregrine Surgical, Ltd. · 2015
  • K132614Peregrine Curved Illuminating Laser ProbePeregrine Surgical, Ltd. · 2013
  • K12299723GA Curved Illuminating Laser ProbePeregrine Surgical, Ltd. · 2013
  • K122905Peregrine 23GA Curved Laser ProbePeregrine Surgical, Ltd. · 2013
  • K031023Peregrine Illuminating Laser Probe Model PD600.10Peregrine Surgical, Ltd. · 20031 recall

Recent decisions in HQF

The HQF category page

  • K252979Voyager DSLT (430840610)Belkin Vision, Ltd. · 2026
  • K251507Integre LioQuantel Medical · 2026
  • K251772Navilas Laser System 577sl (156691)Od-Os GmbH · 2025
  • K243014EyeQ nanoECPEyeq, Inc. · 2025
  • K240615Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc. · 20251 recall

https://510kreport.com/device/K061024 · printed Nov 3, 2026

Cite this page

510(k) Report. “K061024: Peregrine Soft Tip Aspirating Laser Probe, Model PD720.60.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K061024

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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