510(k) · Cleared

Cleared

Epilight Hair Removal System

K963249510(k) TraditionalCleared Jul 7, 1997322-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

Esc Medical Systems, Ltd. · GEX Powered Laser Surgical Instrument

Cleared on Jul 7, 1997 as substantially equivalent to K950019 (Thermolase Corp., 1995) and 1 other predicate after a 322-day review. Its family tree reaches back 1 generation to 1990. 1,499 later devices descend from it.

Decided: Jul 7, 1997
Review: 322 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K892514 (1990). 2 ancestors in all. 1,499 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 1 generation backK892514 Ahrs Epilator 629American Hair Removal System Co. · 1990
This deviceK963249 Epilight Hair Removal SystemEsc Medical Systems, Ltd. · 1997
Descendant · cites it directly · 1,496 of its ownK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
Descendant · cites it directly · 1,492 of its ownK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
Descendant · 2 generations on · 1,129 of its ownK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
Descendant · 3 generations on · 1,127 of its ownK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
Descendant · cites it directly · 1,117 of its ownK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003

Showing 5 of 1,499 descendants. See all descendants

Descendants cleared per year

1998high 162 (2025) · low 0 (2001)2026

Most influential descendants

Showing 5 of 1,499 · See all

K974536Photoderm HR SystemEsc Medical Systems, Ltd. · 1998 · cites it directly1,496descendants
K991935Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000 · cites it directly1,492descendants
K013366Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002 · 2 generations on1,129descendants
K022568Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted HairMedical Bio Care Sweden AB · 2002 · 3 generations on1,127descendants
K023954Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003 · cites it directly1,117descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K892514	Ahrs Epilator 629	American Hair Removal System Co.	1990	—
0 (this device)	K963249	Epilight Hair Removal System	Esc Medical Systems, Ltd.	1997	—
+1	K974536	Photoderm HR System	Esc Medical Systems, Ltd.	1998	—
+1	K991935	Epilight Hair Removal System, Photoderm HR System	Esc Medical Systems, Ltd.	2000	—
+2	K013366	Prolite Pulsed Light System for the Removal of Unwanted Hair	Medical Bio Care Sweden AB	2002	—
+3	K022568	Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair	Medical Bio Care Sweden AB	2002	—
+1	K023954	Altus Medical Coolglide Laser Systems and Accessories	Altus Medical, Inc.	2003	—

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
1998	1	0
1999	1	0
2000	1	0
2002	11	0
2003	24	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 K963249, 1990–2026Source: 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? (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
*	K950019	Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 Summary page 1 …of device: EpiLight™ Hair Removal System Predicate devices: \| 1. LT-100 ND:YAG Laser Hair Removal System made by Thermolase Corporation of San Diego, California. 510K #K950019. 2. Epilator 629 made by American Hair Removal System of Southern Pines, North Carolina. 510K #K892514. Descrinti - device: Epi…	Thermolase Corp.	1995	—
*	K892514	Ahrs Epilator 629 Summary page 1 …m made by Thermolase Corporation of San Diego, California. 510K #K950019. 2. Epilator 629 made by American Hair Removal System of Southern Pines, North Carolina. 510K #K892514. Descrinti - device: EpiLight™ Hair Removal System is an electro optic medical device designed for effective photothermal treatm…	American Hair Removal System Co.	1990	—

Also cleared against K950019: 7 other devices →

What descends from it? (1,499)

See all 1,499

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

Number	Device	Applicant	Decided	Descendants
K974536	Photoderm HR System	Esc Medical Systems, Ltd.	1998	1,496
K991935	Epilight Hair Removal System, Photoderm HR System	Esc Medical Systems, Ltd.	2000	1,492
K023954	Altus Medical Coolglide Laser Systems and Accessories	Altus Medical, Inc.	2003	1,117
K043319	Clareon and Solarus Pulsed Light Devices and Accessories	Novalis Medical, LLC	2004	15
K992482	Delight II Hair Removal System (the Delight System)	Radiancy, Ltd.	1999	10
K030423	Powerlite 600 EP System	Preswede AB	2003	1
K031680	Spectrapulse	Primary Technology, LLC	2003	0

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, K974536 (Esc Medical Systems, Ltd., 1998) has gone furthest, with 1,496 descendants of its own.
7 other devices also cite its predicate K950019.

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 EpiLight Hair Removal System is used for the removal of unwanted hair

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/K963249 · printed Nov 4, 2026

Cite this page

510(k) Report. “K963249: Epilight Hair Removal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963249

Report an extraction error

Are you the manufacturer?

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