510(k) · Cleared

Cleared

Laser Lancet LB100

K980538510(k) TraditionalCleared Jul 9, 1998148-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

Transmedica Intl., Inc. · GEX Powered Laser Surgical Instrument

Cleared on Jul 9, 1998 as substantially equivalent to K955653 (Venisect, Inc., 1997) after a 148-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.

Decided: Jul 9, 1998
Review: 148 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K955653 (1997). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK955653 Venisect Laser LancetVenisect, Inc. · 1997
This deviceK980538 Laser Lancet LB100Transmedica Intl., Inc. · 1998
Descendant · cites it directly · 1 of its ownK021222 Lad, Model Lad-01Norwood Abbey, Ltd. · 2003
Descendant · 2 generations on · 0 of its ownK040525 Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic…Sontra Medical, Inc. · 2004

Most influential descendants

Showing 2 of 2 · See all

K021222Lad, Model Lad-01Norwood Abbey, Ltd. · 2003 · cites it directly1descendant
K040525Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic Kit, Model D2000Sontra Medical, Inc. · 2004 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K955653	Venisect Laser Lancet	Venisect, Inc.	1997	—
0 (this device)	K980538	Laser Lancet LB100	Transmedica Intl., Inc.	1998	—
+1	K021222	Lad, Model Lad-01	Norwood Abbey, Ltd.	2003	—
+2	K040525	Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic Kit, Model…	Sontra Medical, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0

FIG. 1 — Lineage of K980538, 1997–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 GEX? 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 GEX device

#1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K955653	Venisect Laser Lancet Summary page 1 …Name: Surgical Laser (see: 21 CFR 878.4810). Product Code: GEX. Legally marketed Steel Lancet (as described in K931258), Laser Lancet (as described in predicate device: K955653) Device Description: The Laser Lancet® LB100 is a portable Er:YAG laser. The beam is focused within the unit and exits through a…	Venisect, Inc.	1997	—
†	K931258	Softtouch II Lancet Device	Boehringer Mannheim Corp.	1994	—

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
K021222	Lad, Model Lad-01	Norwood Abbey, Ltd.	2003	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?

Its one ancestor has no recall.
Of its descendants, K021222 (Norwood Abbey, Ltd., 2003) has gone furthest, with 1 descendant of its own.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEX

83in 2025

2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007high 152 (2022) · low 78 (2018)2026

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

Recalls per year · GEX

3in 2024

2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, 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	73	79	9	342
2008	107	86	2	232
2009	69	100	0	209
2010	50	96	4	1,711
2011	41	83	18	3,024
2012	45	118	5	2,000
2013	46	144	3	2,236
2014	61	147	6	2,036
2015	47	112	0	2,099
2016	51	114	1	2,585
2017	67	90	5 (1)	2,977
2018	51	78	5	3,525
2019	41	88	6	2,709
2020	52	90	1	2,183
2021	53	123	0	3,465
2022	60	152	0	2,288
2023	52	87	6	2,337
2024	82	90	3	2,187
2025	83	90	0	2,720
2026	57	90	2	—

What is it indicated for?

The Laser Lancet® is intended for use for the perforation of skin to draw capillary blood for screening purposes.

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/K980538 · printed Nov 5, 2026

Cite this page

510(k) Report. “K980538: Laser Lancet LB100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980538

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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