510(k) · Cleared

Cleared

Sharplan CO2 Surgical Laser System

K971743510(k) TraditionalCleared Jul 18, 199767-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

Sharplan Lasers, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Jul 18, 1997 as substantially equivalent to K950725 (Sharplan Lasers, Inc., 1995) and 1 other predicate after a 67-day review. Its family tree reaches back 1 generation to 1995. 4 later devices descend from it.

Decided: Jul 18, 1997
Review: 67 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K950725 (1995). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK950725 Sharplan Model 1015 CO2 LaserSharplan Lasers, Inc. · 1995
This deviceK971743 Sharplan CO2 Surgical Laser SystemSharplan Lasers, Inc. · 1997
Descendant · cites it directly · 3 of its ownK132661 LightscalpelLightscalpel, LLC · 2014
Descendant · cites it directly · 2 of its ownK141658 Light ScalpelLightscalpel, LLC · 2014
Descendant · 2 generations on · 0 of its ownK213669 Lightscalpel LS-4020Lightscalpel, Inc. · 2023
Descendant · 2 generations on · 0 of its ownK173827 LightScalpelLightscalpel, LLC · 2018

Most influential descendants

Showing 4 of 4 · See all

K132661LightscalpelLightscalpel, LLC · 2014 · cites it directly3descendants
K141658Light ScalpelLightscalpel, LLC · 2014 · cites it directly2descendants
K213669Lightscalpel LS-4020Lightscalpel, Inc. · 2023 · 2 generations on0descendants
K173827LightScalpelLightscalpel, LLC · 2018 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K950725	Sharplan Model 1015 CO2 Laser	Sharplan Lasers, Inc.	1995	—
0 (this device)	K971743	Sharplan CO2 Surgical Laser System	Sharplan Lasers, Inc.	1997	—
+1	K132661	Lightscalpel	Lightscalpel, LLC	2014	—
+1	K141658	Light Scalpel	Lightscalpel, LLC	2014	—
+2	K213669	Lightscalpel LS-4020	Lightscalpel, Inc.	2023	—
+2	K173827	LightScalpel	Lightscalpel, LLC	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	2	0
2018	1	0
2023	1	0

FIG. 1 — Lineage of K971743, 1995–2023Source: 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K950725	Sharplan Model 1015 CO2 Laser Summary page 1 …George J. Hattub, Director of Regulatory Affairs/Quality Assurance April 30, 1997 Model: Sharplan Model 15F CO2 Laser Predicate Devices: The Sharplan 15 F CO2 Laser (K950725) and the ILT CO2 Laser System (K954460). Description: The Sharplan Model 15F CO2 Surgical Laser is a medical device which capabl…	Sharplan Lasers, Inc.	1995	—
*	K954460	Ilt Surgical Laser Summary page 1 …ory Affairs/Quality Assurance April 30, 1997 Model: Sharplan Model 15F CO2 Laser Predicate Devices: The Sharplan 15 F CO2 Laser (K950725) and the ILT CO2 Laser System (K954460). Description: The Sharplan Model 15F CO2 Surgical Laser is a medical device which capable of being used as a heat source for ac…	Ion Laser Technology	1995	—

Also cleared against K950725: 2 other devices →

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K132661	Lightscalpel	Lightscalpel, LLC	2014	3
K141658	Light Scalpel	Lightscalpel, LLC	2014	2

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.
Of its descendants, K132661 (Lightscalpel, LLC, 2014) has gone furthest, with 3 descendants of its own.
2 other devices also cite its predicate K950725.

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 Sharplan 15F CO2 Laser System is intended for use as a heat source to activate tooth bleaching materials.

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/K971743 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971743: Sharplan CO2 Surgical Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971743

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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