510(k) · Cleared

Cleared

SLT Contact ND:Yag Laser for Intra-Abdom.&Genital

K872254510(k) TraditionalCleared Dec 14, 1987208-day reviewClass II21 CFR 884.4550

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

Surgical Laser Technologies, Inc. · HHR Laser, Surgical, Gynecologic

Cleared on Dec 14, 1987 after a 208-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided: Dec 14, 1987
Review: 208 days
Class: Class II
Product code: HHR
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK872254 SLT Contact ND:Yag Laser for Intra-Abdom.&GenitalSurgical Laser Technologies, Inc. · 1987
Descendant · cites it directly · 0 of its ownK030033 Lumenis Family of Disposable Contact Tip Delivery DevicesLumenis, Ltd. · 2003

Most influential descendants

Showing 1 of 1 · See all

K030033Lumenis Family of Disposable Contact Tip Delivery DevicesLumenis, Ltd. · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K872254	SLT Contact ND:Yag Laser for Intra-Abdom.&Genital	Surgical Laser Technologies, Inc.	1987	—
+1	K030033	Lumenis Family of Disposable Contact Tip Delivery Devices	Lumenis, Ltd.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K872254, 1987–2003Source: 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 HHR? 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? (1)

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

Number	Device	Applicant	Decided	Descendants
K030033	Lumenis Family of Disposable Contact Tip Delivery Devices	Lumenis, Ltd.	2003	0

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, K030033 (Lumenis, Ltd., 2003) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HHR devices

HHR Laser, Surgical, Gynecologic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HHR

FDA has decided no HHR device since 2007.

Median 510(k) review, days · HHR

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

Recalls per year · HHR

No recall names HHR since 2007.

Adverse event reports per year · HHR

2in 2015

2007high 2 (2015) · low 0 (2008)2025

MAUDE reports naming product code HHR, 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	—	1
2008	—	0
2009	—	0
2010	—	0
2011	—	1
2012	—	0
2013	—	0
2014	—	0
2015	—	2
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K872254 · printed Nov 6, 2026

Cite this page

510(k) Report. “K872254: SLT Contact ND:Yag Laser for Intra-Abdom.&Genital.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K872254

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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