510(k) · Cleared

Cleared

Storz Premiere (R) Microsurgical System

K946227510(k) TraditionalCleared Mar 22, 199590-day reviewClass II21 CFR 886.4670

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

Storz Instrument Co. · HQC Unit, Phacofragmentation

Cleared on Mar 22, 1995 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 51 later devices descend from it.

Decided: Mar 22, 1995
Review: 90 days
Class: Class II
Product code: HQC
Recalls: None
Predicates: 0

51 later devices descend from it, 2 citing it directly.

This deviceK946227 Storz Premiere (R) Microsurgical SystemStorz Instrument Co. · 1995
Descendant · cites it directly · 49 of its ownK993154 Laser Photolysis System, Pharo Ophthalmic Surgery SystemA.R.C. Laser Corp. · 2000 · Recalled
Descendant · 2 generations on · 47 of its ownK094052 Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010
Descendant · 3 generations on · 30 of its ownK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
Descendant · 4 generations on · 19 of its ownK113151 Ifs Laser SystemAbbott Medical Optics, Inc. · 2012
Descendant · 3 generations on · 13 of its ownK113479 Optimedica Catalys Precision Laser SystemOptimedica Corporation · 2011 · Recalled

Showing 5 of 51 descendants. See all descendants

Descendants cleared per year

2000high 7 (2012) · low 0 (2001)2026

Most influential descendants

Showing 5 of 51 · See all

K993154Laser Photolysis System, Pharo Ophthalmic Surgery SystemA.R.C. Laser Corp. · 2000 · cites it directly49descendants
K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010 · 2 generations on47descendants
K101626Lensx Laser SystemLensx Lasers, Inc. · 2010 · 3 generations on30descendants
K113151Ifs Laser SystemAbbott Medical Optics, Inc. · 2012 · 4 generations on19descendants
K113479Optimedica Catalys Precision Laser SystemOptimedica Corporation · 2011 · 3 generations on13descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K946227	Storz Premiere (R) Microsurgical System	Storz Instrument Co.	1995	—
+1	K993154	Laser Photolysis System, Pharo Ophthalmic Surgery System	A.R.C. Laser Corp.	2000	1
+2	K094052	Lensx 550 Laser System. Model 550	Lensx Lasers, Inc.	2010	—
+3	K101626	Lensx Laser System	Lensx Lasers, Inc.	2010	—
+4	K113151	Ifs Laser System	Abbott Medical Optics, Inc.	2012	—
+3	K113479	Optimedica Catalys Precision Laser System	Optimedica Corporation	2011	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2002	1	0
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 K946227, 1995–2025Source: 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 HQC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (51)

See all 51

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

Number	Device	Applicant	Decided	Descendants
K993154	Laser Photolysis System, Pharo Ophthalmic Surgery System	A.R.C. Laser Corp.	2000	49
K022833	Benjamin Envoy Phaco Handpiece	Benjamin Biomedical, Inc.	2002	0

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, K993154 (A.R.C. Laser Corp., 2000) has gone furthest, with 49 descendants of its own.

How does its category compare?

All HQC devices

HQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HQC

3in 2025

2007high 5 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HQC

267in 2025

2007high 267 (2025) · low 124 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HQC

1in 2025

2007high 22 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HQC

1,799in 2025

2007high 3,374 (2016) · low 341 (2007)2025

MAUDE reports naming product code HQC, 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	0	—	0	341
2008	4	162	1	444
2009	5	131	1	540
2010	3	142	22	2,431
2011	5	129	4	1,802
2012	5	125	1	2,277
2013	0	—	0	2,772
2014	4	135	1	2,740
2015	3	124	0	3,355
2016	1	—	0	3,374
2017	3	214	0	2,781
2018	0	—	2	2,416
2019	4	126	0	2,287
2020	4	227	0	1,217
2021	1	—	0	1,673
2022	4	245	5	1,907
2023	1	—	1	1,799
2024	5	197	0	2,120
2025	3	267	1	1,799
2026	3	115	0	—

https://510kreport.com/device/K946227 · printed Nov 5, 2026

Cite this page

510(k) Report. “K946227: Storz Premiere (R) Microsurgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K946227

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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