510(k) · Cleared

Cleared

MDL-2000 Lasertripter

K901723510(k) TraditionalCleared Jul 13, 199088-day reviewClass II21 CFR 878.4810

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

Candela Laser Corp. · LNK Laser For Gastro-Urology Use

Cleared on Jul 13, 1990 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Jul 13, 1990
Review: 88 days
Class: Class II
Product code: LNK
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK901723 MDL-2000 LasertripterCandela Laser Corp. · 1990
Descendant · cites it directly · 1 of its ownK023041 W.O.M. Laser U100W.O.M. World of Medicine AG · 2002
Descendant · 2 generations on · 0 of its ownK032023 W.O.M. Laser U100PLUSW.O.M. World of Medicine AG · 2003

Most influential descendants

Showing 2 of 2 · See all

K023041W.O.M. Laser U100W.O.M. World of Medicine AG · 2002 · cites it directly1descendant
K032023W.O.M. Laser U100PLUSW.O.M. World of Medicine AG · 2003 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K901723	MDL-2000 Lasertripter	Candela Laser Corp.	1990	—
+1	K023041	W.O.M. Laser U100	W.O.M. World of Medicine AG	2002	—
+2	K032023	W.O.M. Laser U100PLUS	W.O.M. World of Medicine AG	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0

FIG. 1 — Lineage of K901723, 1990–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 LNK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K023041	W.O.M. Laser U100	W.O.M. World of Medicine AG	2002	1

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, K023041 (W.O.M. World of Medicine AG, 2002) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LNK devices

LNK Laser For Gastro-Urology Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LNK

FDA has decided no LNK device since 2007.

Median 510(k) review, days · LNK

Too few LNK 510(k)s in any year since 2007 to give a median.

Recalls per year · LNK

No recall names LNK since 2007.

Adverse event reports per year · LNK

2in 2023

2007high 24 (2007) · low 0 (2012)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	24
2008	—	15
2009	—	8
2010	—	4
2011	—	1
2012	—	0
2013	—	1
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	2
2022	—	0
2023	—	2
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K901723 · printed Nov 5, 2026

Cite this page

510(k) Report. “K901723: MDL-2000 Lasertripter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K901723

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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