510(k) · Cleared

Cleared

Sharplan Surgical CO2 Lasers and Accessories

K935563510(k) TraditionalCleared May 17, 1994181-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 May 17, 1994 after a 181-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 378 later devices descend from it.

Decided: May 17, 1994
Review: 181 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

378 later devices descend from it, 4 citing it directly.

This deviceK935563 Sharplan Surgical CO2 Lasers and AccessoriesSharplan Lasers, Inc. · 1994
Descendant · cites it directly · 377 of its ownK991628 Modified LX-20 CO2 Laser System Family, LX-20SAEsc Medical Systems, Inc. · 1999
Descendant · cites it directly · 376 of its ownK022060 Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and…Lumenis, Inc. · 2002
Descendant · 2 generations on · 323 of its ownK030147 Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd. · 2003
Descendant · 2 generations on · 318 of its ownK031795 Reliant Laser SystemReliant Technologies, Inc. · 2003
Descendant · 2 generations on · 316 of its ownK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004

Showing 5 of 378 descendants. See all descendants

Descendants cleared per year

1999high 41 (2024) · low 0 (2000)2026

Most influential descendants

Showing 5 of 378 · See all

K991628Modified LX-20 CO2 Laser System Family, LX-20SAEsc Medical Systems, Inc. · 1999 · cites it directly377descendants
K022060Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesLumenis, Inc. · 2002 · cites it directly376descendants
K030147Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd. · 2003 · 2 generations on323descendants
K031795Reliant Laser SystemReliant Technologies, Inc. · 2003 · 2 generations on318descendants
K040617Reliant Laser System IIReliant Technologies, Inc. · 2004 · 2 generations on316descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K935563	Sharplan Surgical CO2 Lasers and Accessories	Sharplan Lasers, Inc.	1994	—
+1	K991628	Modified LX-20 CO2 Laser System Family, LX-20SA	Esc Medical Systems, Inc.	1999	—
+1	K022060	Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device…	Lumenis, Inc.	2002	—
+2	K030147	Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers	Lumenis, Ltd.	2003	—
+2	K031795	Reliant Laser System	Reliant Technologies, Inc.	2003	—
+2	K040617	Reliant Laser System II	Reliant Technologies, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2002	1	0
2003	3	0
2004	3	0
2005	2	0
2006	3	0
2007	9	0
2008	13	0
2009	7	0
2010	7	0
2011	13	0
2012	8	0
2013	11	0
2014	12	0
2015	12	0
2016	13	0
2017	12	0
2018	22	0
2019	10	0
2020	28	0
2021	19	0
2022	36	0
2023	25	0
2024	41	0
2025	41	0
2026	26	0

FIG. 1 — Lineage of K935563, 1994–2026Source: 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

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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? (378)

See all 378

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

Number	Device	Applicant	Decided	Descendants
K991628	Modified LX-20 CO2 Laser System Family, LX-20SA	Esc Medical Systems, Inc.	1999	377
K022060	Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories	Lumenis, Inc.	2002	376
K050254	Spectra-SP CO2 Laser System	Max Engineering, Ltd.	2005	13
K091320	Spectra SP II, Spectra Denta II	Lutronic Corporation	2009	12

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, K991628 (Esc Medical Systems, Inc., 1999) has gone furthest, with 377 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/K935563 · printed Nov 4, 2026

Cite this page

510(k) Report. “K935563: Sharplan Surgical CO2 Lasers and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K935563

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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