510(k) · Cleared

Recalled · 2003

Laser Photolysis System, Pharo Ophthalmic Surgery System

K993154510(k) TraditionalCleared Jun 29, 2000282-day reviewClass II21 CFR 878.4810Recalls 1

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

A.R.C. Laser Corp. · GEX Powered Laser Surgical Instrument

Cleared on Jun 29, 2000 as substantially equivalent to K952213 (Alcon Laboratories, 1995) and 3 other predicates after a 282-day review. Its family tree reaches back 1 generation to 1989. 49 later devices descend from it. It has been recalled once.

Decided: Jun 29, 2000
Review: 282 days
Class: Class II
Product code: GEX
Recalls: 1
Predicates: 4

Its longest line of descent runs back 1 generation to K894278 (1989). 4 ancestors in all. 49 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK894278 Storz Daisyplus Series Microsurgical SystemsStorz Instrument Co. · 1989
This deviceK993154 Laser Photolysis System, Pharo Ophthalmic Surgery SystemA.R.C. Laser Corp. · 2000
Descendant · cites it directly · 47 of its ownK094052 Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010
Descendant · 2 generations on · 30 of its ownK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
Descendant · 3 generations on · 19 of its ownK113151 Ifs Laser SystemAbbott Medical Optics, Inc. · 2012
Descendant · 2 generations on · 13 of its ownK113479 Optimedica Catalys Precision Laser SystemOptimedica Corporation · 2011 · Recalled
Descendant · 3 generations on · 12 of its ownK120732 Lenssx Laser SystemAlcon Lensx, Inc. · 2012 · Recalled

Showing 5 of 49 descendants. See all descendants

Descendants cleared per year

2010high 7 (2012) · low 0 (2019)2026

Most influential descendants

Showing 5 of 49 · See all

K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010 · cites it directly47descendants
K101626Lensx Laser SystemLensx Lasers, Inc. · 2010 · 2 generations on30descendants
K113151Ifs Laser SystemAbbott Medical Optics, Inc. · 2012 · 3 generations on19descendants
K113479Optimedica Catalys Precision Laser SystemOptimedica Corporation · 2011 · 2 generations on13descendants
K120732Lenssx Laser SystemAlcon Lensx, Inc. · 2012 · 3 generations on12descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K894278	Storz Daisyplus Series Microsurgical Systems	Storz Instrument Co.	1989	—
0 (this device)	K993154	Laser Photolysis System, Pharo Ophthalmic Surgery System	A.R.C. Laser Corp.	2000	—
+1	K094052	Lensx 550 Laser System. Model 550	Lensx Lasers, Inc.	2010	—
+2	K101626	Lensx Laser System	Lensx Lasers, Inc.	2010	—
+3	K113151	Ifs Laser System	Abbott Medical Optics, Inc.	2012	—
+2	K113479	Optimedica Catalys Precision Laser System	Optimedica Corporation	2011	2
+3	K120732	Lenssx Laser System	Alcon Lensx, Inc.	2012	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1995	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	2	0
2011	3	0
2012	7	0
2013	2	0
2014	4	0
2015	6	0
2016	2	0
2017	7	0
2018	6	0
2020	2	0
2021	1	0
2022	3	0
2023	2	0
2025	2	0

FIG. 1 — Lineage of K993154, 1989–2025Source: 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? (5)

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
*	K952213	Alcon Series 20000 Legacy Phacoemulsifier Summary page 1 …QC, HQE, MXO Device Class: Class II Predicate Devices: The Pharo System 1is substantially equivalent to the following legally marketed devices: The Series 20000 Legacy (K952213) marketed by Alcon Laboratories, Inc., the Premiere Microsurgical System (K89478, K921460, K946227) marketed by Storz Instrument…	Alcon Laboratories	1995	—
*	K894278	Storz Daisyplus Series Microsurgical Systems Summary page 1 …rketed by Alcon Laboratories, Inc. The Laser Photolysis System is substantially equivalent to the following legally marketed devices: The Premiere Microsurgical System (K894278, K921460, K946227)marketed by Pharo Ophthalmic Surgery System/Laser Photolysis System /ﬂ >7* ARC Lsaser “& 557 <4…	Storz Instrument Co.	1989	—
*	K921460	Storz Premiere/Premiere Microvit Microsurg Systems Summary page 1 …equivalent to the following legally marketed devices: The Series 20000 Legacy (K952213) marketed by Alcon Laboratories, Inc., the Premiere Microsurgical System (K89478, K921460, K946227) marketed by Storz Instrument Company, and the Alcon Accuras, marketed by Alcon Laboratories, Inc. The Laser Photolysis…	Storz Instrument Co.	1992	—
*	K946227	Storz Premiere (R) Microsurgical System Summary page 1 …nt to the following legally marketed devices: The Series 20000 Legacy (K952213) marketed by Alcon Laboratories, Inc., the Premiere Microsurgical System (K89478, K921460, K946227) marketed by Storz Instrument Company, and the Alcon Accuras, marketed by Alcon Laboratories, Inc. The Laser Photolysis System i…	Storz Instrument Co.	1995	—
*	—	Alcon Accuras Named without a submission number			—

Also cleared against K952213: 5 other devices →

What descends from it? (49)

See all 49

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

Number	Device	Applicant	Decided	Descendants
K094052	Lensx 550 Laser System. Model 550	Lensx Lasers, Inc.	2010	47
K170183	Cetus system, Cetus probe	A.R.C Laser GmbH	2017	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 6, 2003	Not classified	Z-0981-03	Other	Product may not have been properly sterilized.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 4 ancestors has a recall.
Of its descendants, K094052 (Lensx Lasers, Inc., 2010) has gone furthest, with 47 descendants of its own.
5 other devices also cite its predicate K952213.

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 Laser Photolysis System is indicated for use in phacofragmentation of the cataractous crystalline lens.

The Pharo Ophthalmic Surgery System is indicated for use in phacofragmentation of the cataractous crystalline lens, and anterior and posterior ophthalmic surgery.

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/K993154 · printed Nov 4, 2026

Cite this page

510(k) Report. “K993154: Laser Photolysis System, Pharo Ophthalmic Surgery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993154

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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