510(k) · Cleared

Cleared

Photex Diode Laser Series, Models 980, 810 and 940

K060304510(k) TraditionalCleared Mar 21, 200643-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

Biotex, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Mar 21, 2006 as substantially equivalent to K952661 (Surgical Laser Technologies, Inc., 1995) after a 43-day review. Its family tree reaches back 1 generation to 1995. 2 of the 44 devices in its family, counting itself, have a Class I recall. 42 later devices descend from it.

Decided: Mar 21, 2006
Review: 43 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K952661 (1995). 42 later devices descend from it, 5 citing it directly. 2 of the 44 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK952661 SLT Thermalite Diode Laser Series, Diode 980, 810, 940Surgical Laser Technologies, Inc. · 1995
This deviceK060304 Photex Diode Laser Series, Models 980, 810 and 940Biotex, Inc. · 2006
Descendant · cites it directly · 26 of its ownK071328 Visualase Thermal Therapy SystemBiotex, Inc. · 2007 · Recalled
Descendant · 2 generations on · 22 of its ownK081509 Monteris Medical Autolitt Laser ProbeMonteris Medical, · 2009
Descendant · 3 generations on · 21 of its ownK120561 Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
Descendant · 4 generations on · 19 of its ownK131955 Neuroblate (TM) SystemMonteris Medical, Inc. · 2013 · Recalled
Descendant · 4 generations on · 19 of its ownK131278 Monteris Medical Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled

Showing 5 of 42 descendants. See all descendants

Descendants cleared per year

2007high 4 (2017) · low 0 (2011)2026

Class I recalls in this family

K143457 NeuroBlate System5 generations on · 2015
K171255 Monteris Medical NeuroBlate System5 generations on · 2017

Most influential descendants

Showing 5 of 42 · See all

K071328Visualase Thermal Therapy SystemBiotex, Inc. · 2007 · cites it directly26descendants
K081509Monteris Medical Autolitt Laser ProbeMonteris Medical, · 2009 · 2 generations on22descendants
K120561Neuroblate SystemMonteris Medical, Inc. · 2013 · 3 generations on21descendants
K131955Neuroblate (TM) SystemMonteris Medical, Inc. · 2013 · 4 generations on19descendants
K131278Monteris Medical Neuroblate SystemMonteris Medical, Inc. · 2013 · 4 generations on19descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K952661	SLT Thermalite Diode Laser Series, Diode 980, 810, 940	Surgical Laser Technologies, Inc.	1995	—
0 (this device)	K060304	Photex Diode Laser Series, Models 980, 810 and 940	Biotex, Inc.	2006	—
+1	K071328	Visualase Thermal Therapy System	Biotex, Inc.	2007	1
+2	K081509	Monteris Medical Autolitt Laser Probe	Monteris Medical,	2009	—
+3	K120561	Neuroblate System	Monteris Medical, Inc.	2013	1
+4	K131955	Neuroblate (TM) System	Monteris Medical, Inc.	2013	2
+4	K131278	Monteris Medical Neuroblate System	Monteris Medical, Inc.	2013	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	3	0
2008	3	0
2009	3	0
2010	2	0
2013	3	0
2014	1	0
2015	3	1
2016	1	0
2017	4	1
2018	2	0
2019	2	0
2020	3	0
2022	2	0
2023	2	0
2024	2	0
2025	3	0
2026	3	0

FIG. 1 — Lineage of K060304, 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.

2 devices in this family have a Class I recall. 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? (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
*	K952661	SLT Thermalite Diode Laser Series, Diode 980, 810, 940 Summary page 1 …X RegClass: II Reg. Number 878.4810 Predicate Device SLT Thermallte Diode Laser Series: 980, 810, 940 (K952661) Description of Device The PhoTexis Diode Laser Series are diode lasers emitting radiation in either a continuous-wave (CW) or…	Surgical Laser Technologies, Inc.	1995	—
*	—	PhotoMedex LaserPro Diode Laser Systems Named without a submission number			—

Also cleared against K952661: 4 other devices →

What descends from it? (42)

See all 42

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

Number	Device	Applicant	Decided	Descendants
K071328	Visualase Thermal Therapy System	Biotex, Inc.	2007	26
K062363	BWF-5 Medical Laser Series, 810 NM; 930 NM; 980 NM; 1080 NM	B&W Tek, Inc.	2007	11
K092197	PHOTEX30 Diode Laser Series: 980, 810, 940	Biotex, Inc.	2009	2
K093087	BWF-5 Medical Laser Series	Litecure, LLC	2010	0
K071815	Noveon, Model LS1100-01-0968	Nomir Medical Technologies, Inc.	2007	0

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K143457NeuroBlate SystemMonteris Medical, Inc. · 2015 · 5 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
K171255Monteris Medical NeuroBlate SystemMonteris Medical, Inc. · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K071328 (Biotex, Inc., 2007) has gone furthest, with 26 descendants of its own.
4 other devices also cite its predicate K952661.

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 PhoTexl 5 Diode Laser Series is indicated for use in surgical applications requiring the

ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery

including: gastroenterology, general surgery, plastic surgery, genitourinary (urology),

gynecology (GYN), neurosurgery, otolaryngology (ENT) head and neck, orthopedics,

ophthalmology, pulmonology, and thoracic surgery.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060304 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060304: Photex Diode Laser Series, Models 980, 810 and 940.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060304

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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