510(k) · Cleared

Cleared

Schwartz Electro-Optics, Inc. CLR 2940 Erbium Crystalase

K980313510(k) TraditionalCleared Mar 19, 199851-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

Schwartz Electro-Optics, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Mar 19, 1998 as substantially equivalent to K974039 (Schwartz Electro-Optics, Inc., 1998) and 1 other predicate after a 51-day review. Its family tree reaches back 4 generations to 1996.

Decided: Mar 19, 1998
Review: 51 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K954013 (1996). 7 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK954013 Trilase 2940 Erbium LaserSchwartz Electro-Optics, Inc. · 1996
3 generations backK961748 Medlite/Erbium Laser SystemContinuum Biomedical, Inc. · 1996
2 generations backK964128 MCL 29 Dermablate Erbium Laser SystemAesculap-Meditec GmbH · 1997
1 generation backK971648 Sharplan Erbium: Yag Laser (4020)Sharplan Lasers, Inc. · 1997
This deviceK980313 Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystalaseSchwartz Electro-Optics, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K954013	Trilase 2940 Erbium Laser	Schwartz Electro-Optics, Inc.	1996	—
−3	K961748	Medlite/Erbium Laser System	Continuum Biomedical, Inc.	1996	—
−2	K964128	MCL 29 Dermablate Erbium Laser System	Aesculap-Meditec GmbH	1997	—
−1	K971648	Sharplan Erbium: Yag Laser (4020)	Sharplan Lasers, Inc.	1997	—
0 (this device)	K980313	Schwartz Electro-Optics, Inc. CLR 2940 Erbium Crystalase	Schwartz Electro-Optics, Inc.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1997	1	0
1998	1	0

FIG. 1 — Lineage of K980313, 1996–1998Source: 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
*	K974039	Schwartz Electro-Optics, Inc. CLR 2940 Erbium Crystalase Summary page 1 …l equivalence as well as the safety and effectiveness of its predicate devices which include the following: the Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase (K974039) and the Sharplan 4020 Erbium Surgical Laser (K971648). L Company: Schwartz Electro-Optics, Inc. 3404 North Orange Blossom Trai…	Schwartz Electro-Optics, Inc.	1998	—
*	K971648	Sharplan Erbium: Yag Laser (4020) Summary page 1 …of its predicate devices which include the following: the Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase (K974039) and the Sharplan 4020 Erbium Surgical Laser (K971648). L Company: Schwartz Electro-Optics, Inc. 3404 North Orange Blossom Trail Orlando, FL. 32804 Timothy J. Shea, Senior Director…	Sharplan Lasers, Inc.	1997	—

Also cleared against K974039: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 2 years and passes through 4 companies; a new generation was cleared every 8 months on median.
None of the 7 ancestors has a recall.
1 other device also cites its predicate K974039.

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?

As previously cleared, the Schwartz Electro-Optics, Inc. CLR 2940 is indicated for use in small and large joint Arthroscopy, including laparoscopic procedures, general and all surgical procedures for cutting (incision/excision), vaporizing, ablating and coagulating soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The CLR 2940 may also be used for skin resurfacing and the treatment of wrinkles.

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/K980313 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980313: Schwartz Electro-Optics, Inc. CLR 2940 Erbium Crystalase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980313

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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