510(k) · Cleared

Cleared

Dermalase

K971459510(k) TraditionalCleared Jul 18, 199788-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

Endo Technic Corp. · GEX Powered Laser Surgical Instrument

Cleared on Jul 18, 1997 as substantially equivalent to K961748 (Continuum Biomedical, Inc., 1996) and 3 other predicates after an 88-day review. Its family tree reaches back 3 generations to 1996. 6 later devices descend from it.

Decided: Jul 18, 1997
Review: 88 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K954013 (1996). 4 ancestors in all, the oldest K952118 (1995). 6 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backK954013 Trilase 2940 Erbium LaserSchwartz Electro-Optics, Inc. · 1996
2 generations backK961748 Medlite/Erbium Laser SystemContinuum Biomedical, Inc. · 1996
1 generation backK964128 MCL 29 Dermablate Erbium Laser SystemAesculap-Meditec GmbH · 1997
This deviceK971459 DermalaseEndo Technic Corp. · 1997
Descendant · cites it directly · 5 of its ownK052354 Oculase MDBiolase Technology, Inc. · 2006
Descendant · 2 generations on · 2 of its ownK063867 Cutera ER:Ysgg Laser HandpieceCutera, Inc. · 2007
Descendant · 3 generations on · 1 of its ownK080530 Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc. · 2008
Descendant · 4 generations on · 0 of its ownK210183 Waterlase iPLusBiolase, Inc. · 2022
Descendant · 2 generations on · 0 of its ownK141975 Waterlase Iplus SBiolase, Inc. · 2015

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2006high 2 (2007) · low 0 (2009)2026

Most influential descendants

Showing 5 of 6 · See all

K052354Oculase MDBiolase Technology, Inc. · 2006 · cites it directly5descendants
K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc. · 2007 · 2 generations on2descendants
K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc. · 2008 · 3 generations on1descendant
K210183Waterlase iPLusBiolase, Inc. · 2022 · 4 generations on0descendants
K141975Waterlase Iplus SBiolase, Inc. · 2015 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K954013	Trilase 2940 Erbium Laser	Schwartz Electro-Optics, Inc.	1996	—
−2	K961748	Medlite/Erbium Laser System	Continuum Biomedical, Inc.	1996	—
−1	K964128	MCL 29 Dermablate Erbium Laser System	Aesculap-Meditec GmbH	1997	—
0 (this device)	K971459	Dermalase	Endo Technic Corp.	1997	—
+1	K052354	Oculase MD	Biolase Technology, Inc.	2006	—
+2	K063867	Cutera ER:Ysgg Laser Handpiece	Cutera, Inc.	2007	—
+3	K080530	Modification to Cutera ER:Ysgg Laser Handpiece	Cutera, Inc.	2008	—
+4	K210183	Waterlase iPLus	Biolase, Inc.	2022	—
+2	K141975	Waterlase Iplus S	Biolase, Inc.	2015	—

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
2006	1	0
2007	2	0
2008	1	0
2015	1	0
2022	1	0

FIG. 1 — Lineage of K971459, 1996–2022Source: 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? (4)

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
*	K961748	Medlite/Erbium Laser System Summary page 1 …Lase™ Common Name: Surgical Laser Classification Name: Surgical Laser System Classification Code: 79GEX EQUIVALENT DEVICES: CB Erbium/2.94 Continuum Biomedical, Inc. K961748 Trilase 2940™ Erbium laser system Schwartz Electro-Optics ~ K954013 MCL 29 Dermablate™ Aesculap-Meditec K964128 Elmer™ Biolase Te…	Continuum Biomedical, Inc.	1996	—
*	K954013	Trilase 2940 Erbium Laser Summary page 1 …er System Classification Code: 79GEX EQUIVALENT DEVICES: CB Erbium/2.94 Continuum Biomedical, Inc. K961748 Trilase 2940™ Erbium laser system Schwartz Electro-Optics ~ K954013 MCL 29 Dermablate™ Aesculap-Meditec K964128 Elmer™ Biolase Technology, Inc. K952118 DESCRIPTION OF THE DEVICE: The DermaLase™ l…	Schwartz Electro-Optics, Inc.	1996	—
*	K964128	MCL 29 Dermablate Erbium Laser System Summary page 1 …ALENT DEVICES: CB Erbium/2.94 Continuum Biomedical, Inc. K961748 Trilase 2940™ Erbium laser system Schwartz Electro-Optics ~ K954013 MCL 29 Dermablate™ Aesculap-Meditec K964128 Elmer™ Biolase Technology, Inc. K952118 DESCRIPTION OF THE DEVICE: The DermaLase™ laser system consists of two main components:…	Aesculap-Meditec GmbH	1997	—
*	K952118	ELMER Summary page 1 …Biomedical, Inc. K961748 Trilase 2940™ Erbium laser system Schwartz Electro-Optics ~ K954013 MCL 29 Dermablate™ Aesculap-Meditec K964128 Elmer™ Biolase Technology, Inc. K952118 DESCRIPTION OF THE DEVICE: The DermaLase™ laser system consists of two main components: the laser module and the delivery syste…	Biological Technology Corp.	1995	—

Also cleared against K961748: 9 other devices →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K052354	Oculase MD	Biolase Technology, Inc.	2006	5

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 1 year and passes through 4 companies; a new generation was cleared every 6 months on median.
None of the 4 ancestors has a recall.
Of its descendants, K052354 (Biolase Technology, Inc., 2006) has gone furthest, with 5 descendants of its own.
9 other devices also cite its predicate K961748.

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?

Use of the device is indicated for the incision, excision, ablation, vaporization and coagulation of dermatologic tissues including epidermal nevi, cheilitis, keloids, verrucae, skin tags, keratosis, scar revision, debulking of tumors, cysts, diagnostic biopsy and skin resurfacing.

Use of the device is further indicated for the incision, excision, vaporization and coagulation of soft tissue during general surgical applications where skin incision, tissue disection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated

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/K971459 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971459: Dermalase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971459

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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