510(k) · Cleared

Cleared

Lightsheer

K980420510(k) TraditionalCleared May 4, 199890-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

Palomar Medical Products, Inc. · GEX Powered Laser Surgical Instrument

Cleared on May 4, 1998 as substantially equivalent to K963947 (Spectrum Medical Technologies, Inc., 1997) after a 90-day review. Its family tree reaches back 2 generations to 1995. 1,494 later devices descend from it.

Decided: May 4, 1998
Review: 90 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K950019 (1995). 3 ancestors in all. 1,494 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
1 generation backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
This deviceK980420 LightsheerPalomar Medical Products, Inc. · 1998
Descendant · cites it directly · 1,493 of its ownK982980 Lightsheer Long Pulse Ruby LaserPalomar Medical Products, Inc. · 1999
Descendant · 2 generations on · 1,492 of its ownK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
Descendant · 3 generations on · 1,117 of its ownK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
Descendant · 3 generations on · 1,046 of its ownK020839 Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002
Descendant · 3 generations on · 1,018 of its ownK020453 Palomar Estelux Pulsed Light System and Palomar CoolrollerPalomar Medical Technologies, Inc. · 2002

Showing 5 of 1,494 descendants. See all descendants

Descendants cleared per year

1999high 162 (2025) · low 0 (2001)2026

Most influential descendants

Showing 5 of 1,494 · See all

K982980Lightsheer Long Pulse Ruby LaserPalomar Medical Products, Inc. · 1999 · cites it directly1,493descendants
K991935Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000 · 2 generations on1,492descendants
K023954Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003 · 3 generations on1,117descendants
K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002 · 3 generations on1,046descendants
K020453Palomar Estelux Pulsed Light System and Palomar CoolrollerPalomar Medical Technologies, Inc. · 2002 · 3 generations on1,018descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K950019	Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100	Thermolase Corp.	1995	—
−1	K963947	Epilaser Normal Mode Ruby Laser	Spectrum Medical Technologies, Inc.	1997	—
0 (this device)	K980420	Lightsheer	Palomar Medical Products, Inc.	1998	—
+1	K982980	Lightsheer Long Pulse Ruby Laser	Palomar Medical Products, Inc.	1999	—
+2	K991935	Epilight Hair Removal System, Photoderm HR System	Esc Medical Systems, Ltd.	2000	—
+3	K023954	Altus Medical Coolglide Laser Systems and Accessories	Altus Medical, Inc.	2003	—
+3	K020839	Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL	Lumenis, Inc.	2002	—
+3	K020453	Palomar Estelux Pulsed Light System and Palomar Coolroller	Palomar Medical Technologies, Inc.	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2000	1	0
2002	8	0
2003	23	0
2004	14	0
2005	26	0
2006	27	0
2007	32	0
2008	49	0
2009	37	0
2010	38	0
2011	37	0
2012	35	0
2013	55	0
2014	61	0
2015	52	0
2016	70	0
2017	69	0
2018	63	0
2019	55	0
2020	62	0
2021	79	0
2022	114	0
2023	107	0
2024	123	0
2025	162	0
2026	94	0

FIG. 1 — Lineage of K980420, 1995–2026Source: 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

Get a 510(k) Report

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
*	K963947	Epilaser Normal Mode Ruby Laser Summary page 2 …eer™ is a prescription device (12 CFR 801.109) The specifications, performance and intended use of the LightSheer™ are the same or similar as the EpiLaser® described in K963947. The differences between the lasers are not significant in terms of the performance or intended use of the LightSheer™ None requ…	Spectrum Medical Technologies, Inc.	1997	—

Also cleared against K963947: 6 other devices →

What descends from it? (1,494)

See all 1,494

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

Number	Device	Applicant	Decided	Descendants
K982980	Lightsheer Long Pulse Ruby Laser	Palomar Medical Products, Inc.	1999	1,493

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 3 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
None of the 3 ancestors has a recall.
Of its descendants, K982980 (Palomar Medical Products, Inc., 1999) has gone furthest, with 1,493 descendants of its own.
6 other devices also cite its predicate K963947.

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 LightSheer™ is intended to effect haix removal of patients with skin types 1 - 4 through selective targeting of melanin in hair follicles.

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/K980420 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980420: Lightsheer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980420

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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