510(k) · Cleared

Cleared

KTP/532 Surgical Laser for Percutaneous Diskectomy

K896183510(k) TraditionalCleared Feb 2, 1990100-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

Laserscope · GEX Powered Laser Surgical Instrument

Cleared on Feb 2, 1990 after a 100-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 21 later devices descend from it.

Decided: Feb 2, 1990
Review: 100 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

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

This deviceK896183 KTP/532 Surgical Laser for Percutaneous DiskectomyLaserscope · 1990
Descendant · cites it directly · 20 of its ownK974464 Oratec Spinecath Intradiscal CatheterOratec Interventions, Inc. · 1998
Descendant · 2 generations on · 16 of its ownK993854 Ora-50 S Autotemp Electrothermal Spine System and AccessoriesOratec Interventions, Inc. · 1999
Descendant · 3 generations on · 14 of its ownK033981 Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975Smith & Nephew, Inc. · 2004
Descendant · 4 generations on · 11 of its ownK130689 Symphony RF GeneratorThermigen, Inc. · 2013
Descendant · 5 generations on · 6 of its ownK171094 Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C · 2017

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

1998high 3 (2016) · low 0 (2000)2026

Most influential descendants

Showing 5 of 21 · See all

K974464Oratec Spinecath Intradiscal CatheterOratec Interventions, Inc. · 1998 · cites it directly20descendants
K993854Ora-50 S Autotemp Electrothermal Spine System and AccessoriesOratec Interventions, Inc. · 1999 · 2 generations on16descendants
K033981Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975Smith & Nephew, Inc. · 2004 · 3 generations on14descendants
K130689Symphony RF GeneratorThermigen, Inc. · 2013 · 4 generations on11descendants
K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C · 2017 · 5 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K896183	KTP/532 Surgical Laser for Percutaneous Diskectomy	Laserscope	1990	—
+1	K974464	Oratec Spinecath Intradiscal Catheter	Oratec Interventions, Inc.	1998	—
+2	K993854	Ora-50 S Autotemp Electrothermal Spine System and Accessories	Oratec Interventions, Inc.	1999	—
+3	K033981	Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975	Smith & Nephew, Inc.	2004	—
+4	K130689	Symphony RF Generator	Thermigen, Inc.	2013	—
+5	K171094	Thermi Reusable Non-invasive RF Electrode	Thermgen, L.L.C	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	2	0
2002	1	0
2004	1	0
2006	1	0
2007	2	0
2008	1	0
2013	1	0
2016	3	0
2017	2	0
2018	1	0
2023	2	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K896183, 1990–2026Source: 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 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

Get a 510(k) Report

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? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K974464	Oratec Spinecath Intradiscal Catheter	Oratec Interventions, Inc.	1998	20

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, K974464 (Oratec Interventions, Inc., 1998) has gone furthest, with 20 descendants 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	—

https://510kreport.com/device/K896183 · printed Nov 6, 2026

Cite this page

510(k) Report. “K896183: KTP/532 Surgical Laser for Percutaneous Diskectomy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K896183

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026