510(k) · Cleared

Recalled · Class II · 2019

Pharos Excimer Laser System, Model EX-308

K062963510(k) TraditionalCleared Apr 3, 2007186-day reviewClass II21 CFR 878.4810Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ra Medical Systems,Inc · GEX Powered Laser Surgical Instrument

Cleared on Apr 3, 2007 as substantially equivalent to K993328 (Surgilight, Inc., 2000) and 12 other predicates after a 186-day review. Its family tree reaches back 5 generations to 1989. 3 later devices descend from it. It has been recalled 2 times.

Decided: Apr 3, 2007
Review: 186 days
Class: Class II
Product code: GEX
Recalls: 2
Predicates: 13

Its longest line of descent runs back 5 generations to K885026 (1989). 21 ancestors in all, the oldest K885025 (1989). 3 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 5 generations backK885026 Houva II UvbNational Biological Corp. · 1989
4 generations backK992914 Excimer Laser Phototherapy System, AL7000Acculase, Inc. · 2000
3 generations backK020591 BclearLumenis · 2002
2 generations backK022165 Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2Theralight, Inc. · 2002
1 generation backK024020 Theralight UV120-2 Uva/Uvb Phototherapy SystemTheralight, Inc. · 2003
This deviceK062963 Pharos Excimer Laser System, Model EX-308Ra Medical Systems,Inc · 2007
Descendant · cites it directly · 2 of its ownK172639 PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co., Ltd. · 2017
Descendant · 2 generations on · 1 of its ownK191501 PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co., Ltd. · 2020
Descendant · 3 generations on · 0 of its ownK223588 PALLAS PremiumLaseroptek Co., Ltd. · 2023

Most influential descendants

Showing 3 of 3 · See all

K172639PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co., Ltd. · 2017 · cites it directly2descendants
K191501PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co., Ltd. · 2020 · 2 generations on1descendant
K223588PALLAS PremiumLaseroptek Co., Ltd. · 2023 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K885026	Houva II Uvb	National Biological Corp.	1989	—
−4	K992914	Excimer Laser Phototherapy System, AL7000	Acculase, Inc.	2000	—
−3	K020591	Bclear	Lumenis	2002	—
−2	K022165	Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2	Theralight, Inc.	2002	—
−1	K024020	Theralight UV120-2 Uva/Uvb Phototherapy System	Theralight, Inc.	2003	—
0 (this device)	K062963	Pharos Excimer Laser System, Model EX-308	Ra Medical Systems,Inc	2007	—
+1	K172639	PALLAS 308/311 Solid-State UV Laser System	Laseroptek Co., Ltd.	2017	—
+2	K191501	PALLAS 308/311 Solid-State UV Laser System	Laseroptek Co., Ltd.	2020	—
+3	K223588	PALLAS Premium	Laseroptek Co., Ltd.	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	2	0
1993	3	0
1995	1	0
2000	1	0
2001	3	0
2002	3	0
2003	1	0
2004	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0
2020	1	0
2023	1	0

FIG. 1 — Lineage of K062963, 1989–2023Source: 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? (13)

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
*	K993328	Surgilight, Inc Excimer Laser Summary page 1 …in dermatology (21 CER §878.48 10). Product Code: GEX Predicate Device: SurgiLight Inc. EX-308 Excimer Laser, 5 10(k) numbers: K993328 and K020973. P ho to Medex XTR.AC Excimer Laser, model AL7000, 510(k) numbers:…	Surgilight, Inc.	2000	—
*	K020973	EX-308 Excimer Laser for Phototherapy Treatment of Vitiligo Summary page 1 …in dermatology (21 CER §878.48 10). Product Code: GEX Predicate Device: SurgiLight Inc. EX-308 Excimer Laser, 5 10(k) numbers: K993328 and K020973. P ho to Medex XTR.AC Excimer Laser, model AL7000, 510(k) numbers:…	Surgilight, Inc.	2002	—
*	K992914	Excimer Laser Phototherapy System, AL7000 Summary page 1 …(k) numbers: K993328 and K020973. P ho to Medex XTR.AC Excimer Laser, model AL7000, 510(k) numbers: K992914, K(003705, K020847, and KO011382 XTRAC Excimner Laser, model AL8000, 510(k) number: K(041943…	Acculase, Inc.	2000	—
*	K003705	Xtrac Excimer Laser System, Model AL7000 Summary page 1 …: K993328 and K020973. P ho to Medex XTR.AC Excimer Laser, model AL7000, 510(k) numbers: K992914, K(003705, K020847, and KO011382 XTRAC Excimner Laser, model AL8000, 510(k) number: K(041943…	Photo Medex, Inc.	2001	—
*	K020847	Xtrac Excimer Laser System, Model AL7000 Summary page 1 …8 and K020973. P ho to Medex XTR.AC Excimer Laser, model AL7000, 510(k) numbers: K992914, K(003705, K020847, and KO011382 XTRAC Excimner Laser, model AL8000, 510(k) number: K(041943 Lumins I…	Photo Medex, Inc.	2002	—
*	K011382	Xtrac Excimer Laser System, Model AL 7000 Summary page 1 …P ho to Medex XTR.AC Excimer Laser, model AL7000, 510(k) numbers: K992914, K(003705, K020847, and KO011382 XTRAC Excimner Laser, model AL8000, 510(k) number: K(041943 Lumins Inc.…	Photo Medex, Inc.	2001	—
*	K041943	Xtrac XL, Model AL8000 Summary page 1 …model AL7000, 510(k) numbers: K992914, K(003705, K020847, and KO011382 XTRAC Excimner Laser, model AL8000, 510(k) number: K(041943 Lumins Inc. BClear Targeted PhotoClearing System, 5 10(k) numbers:…	Photo Medex, Inc.	2004	—
*	K011197	Dermaclear UV-B Phototherapy System Summary page 1 …8000, 510(k) number: K(041943 Lumins Inc. BClear Targeted PhotoClearing System, 5 10(k) numbers: KO(011197, K020591 and 1(021762. TheraLight, hic. Targeted UVA I UVB Phototherapy System, mo…	Lumenis	2001	—
*	K020591	Bclear Summary page 1 …0(k) number: K(041943 Lumins Inc. BClear Targeted PhotoClearing System, 5 10(k) numbers: KO(011197, K020591 and 1(021762. TheraLight, hic. Targeted UVA I UVB Phototherapy System, model UTV12…	Lumenis	2002	—
*	K021762	Bclear Summary page 1 …(041943 Lumins Inc. BClear Targeted PhotoClearing System, 5 10(k) numbers: KO(011197, K020591 and 1(021762. TheraLight, hic. Targeted UVA I UVB Phototherapy System, model UTV120-2…	Lumenis, Inc.	2002	—
*	K024020	Theralight UV120-2 Uva/Uvb Phototherapy System Summary page 1 …TheraLight, hic. Targeted UVA I UVB Phototherapy System, model UTV120-2 UTVA/UJVB, 510(k) numbers: K(024020 and K(022165. National Biological Corp. Houva 3 With PhotoSense II, 5 10(k) number…	Theralight, Inc.	2003	—
*	K022165	Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2 Summary page 1 …TheraLight, hic. Targeted UVA I UVB Phototherapy System, model UTV120-2 UTVA/UJVB, 510(k) numbers: K(024020 and K(022165. National Biological Corp. Houva 3 With PhotoSense II, 5 10(k) numbers K(041212 =…	Theralight, Inc.	2002	—
*	K041212	Houva 3 Phototherapy System Summary page 1 …UTVA/UJVB, 510(k) numbers: K(024020 and K(022165. National Biological Corp. Houva 3 With PhotoSense II, 5 10(k) numbers K(041212 Device Description: RA Medical Systems, Inc.'s PHAROS Excimer Laser is a medical laser that i…	National Biological Corp.	2004	1

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K172639	PALLAS 308/311 Solid-State UV Laser System	Laseroptek Co., Ltd.	2017	2

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 23, 2019	Class II	Z-1631-2020	Software change control	At doses of less than 100 mJ, in custom and auto repeat modes, a software error in the excimer laser phototherapy system causes the device to fail to cease firing as long as the foot pedal or handpiece switch is depressed. This…
Jun 30, 2014	Class II	Z-2123-2014	Error in labeling	RA Medical Systems is recalling the PHAROS EX-308 Excimer Laser because there is a possibility that the laser may calibrate with the iris closed.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
1 of the 21 ancestors has a recall of any class.
Of its descendants, K172639 (Laseroptek Co., Ltd., 2017) has gone furthest, with 2 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. 2007, this device’s year, is highlighted.

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 PHAROS Excimer Laser will be indicated for use for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062963 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062963: Pharos Excimer Laser System, Model EX-308.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062963

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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