510(k) · Cleared

Cleared

DLR-1 Derma-Lase Ruby Laser/DLR-1/Derma-Lase Syst

K924647510(k) TraditionalCleared Jun 4, 1993263-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

Derma-Lase Co. · GEX Powered Laser Surgical Instrument

Cleared on Jun 4, 1993 after a 263-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1,499 later devices descend from it.

Decided: Jun 4, 1993
Review: 263 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

1,499 later devices descend from it, 1 citing it directly.

This deviceK924647 DLR-1 Derma-Lase Ruby Laser/DLR-1/Derma-Lase SystDerma-Lase Co. · 1993
Descendant · cites it directly · 1,498 of its ownK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
Descendant · 2 generations on · 1,497 of its ownK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
Descendant · 3 generations on · 1,496 of its ownK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
Descendant · 4 generations on · 1,492 of its ownK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
Descendant · 4 generations on · 1,129 of its ownK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002

Showing 5 of 1,499 descendants. See all descendants

Descendants cleared per year

1996high 162 (2025) · low 0 (1999)2026

Most influential descendants

Showing 5 of 1,499 · See all

K961279Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996 · cites it directly1,498descendants
K962446Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997 · 2 generations on1,497descendants
K974536Photoderm HR SystemEsc Medical Systems, Ltd. · 1998 · 3 generations on1,496descendants
K991935Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000 · 4 generations on1,492descendants
K013366Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002 · 4 generations on1,129descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K924647	DLR-1 Derma-Lase Ruby Laser/DLR-1/Derma-Lase Syst	Derma-Lase Co.	1993	—
+1	K961279	Sharplan Lasers, Inc. Ruby Laser System	Sharplan Lasers, Inc.	1996	—
+2	K962446	Sharplan Ruby Laser System	Sharplan Lasers, Inc.	1997	—
+3	K974536	Photoderm HR System	Esc Medical Systems, Ltd.	1998	—
+4	K991935	Epilight Hair Removal System, Photoderm HR System	Esc Medical Systems, Ltd.	2000	—
+4	K013366	Prolite Pulsed Light System for the Removal of Unwanted Hair	Medical Bio Care Sweden AB	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1997	1	0
1998	1	0
2000	1	0
2002	11	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 K924647, 1993–2026Source: 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

Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1,499)

See all 1,499

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

Number	Device	Applicant	Decided	Descendants
K961279	Sharplan Lasers, Inc. Ruby Laser System	Sharplan Lasers, Inc.	1996	1,498

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, K961279 (Sharplan Lasers, Inc., 1996) has gone furthest, with 1,498 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/K924647 · printed Nov 6, 2026

Cite this page

510(k) Report. “K924647: DLR-1 Derma-Lase Ruby Laser/DLR-1/Derma-Lase Syst.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924647

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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