510(k) Report

510(k) · Cleared

Cleared

Epiphany Injection System

K090161510(k) TraditionalCleared Jun 9, 2009138-day reviewClass I21 CFR 886.4300

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

Staar Surgical Co. · MSS Folders And Injectors, Intraocular Lens (Iol)

Cleared on Jun 9, 2009 as substantially equivalent to K052651 (Rayner Surgical, Inc., 2006) and 5 other predicates after a 138-day review. Its family tree reaches back 3 generations to 1992. 3 later devices descend from it.

Decided
Jun 9, 2009
Review
138 days
Class
Class I
Product code
MSS
Recalls
None
Predicates
6

Its longest line of descent runs back 3 generations to K914311 (1992). 7 ancestors in all. 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2000: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor2010: 1 descendant cleared2017: 1 descendant cleared2015: 1 descendant clearedK914311 · Chiroflex II Lens Microsert (TM) · Chiron Ophthalmics · 1992K970727 · Mport Foldable Lens Placement System · Chiron Vision Corp. · 1997 · recalledK052651 · C-Flex System Single Use Disposable Injector, Model R-Inj-02 · Rayner Surgical, Inc. · 20061990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants K052651 · C-Flex System Single Use Disposable Injector, Model R-Inj-02 · Rayner Surgical, Inc. · 2006K970727 · Mport Foldable Lens Placement System · Chiron Vision Corp. · 1997 · recalledK914311 · Chiroflex II Lens Microsert (TM) · Chiron Ophthalmics · 19920
  1. Root · 3 generations backK914311 Chiroflex II Lens Microsert (TM)Chiron Ophthalmics · 1992
  2. 2 generations backK970727 Mport Foldable Lens Placement SystemChiron Vision Corp. · 1997 · Recalled
  3. 1 generation backK052651 C-Flex System Single Use Disposable Injector, Model R-Inj-02Rayner Surgical, Inc. · 2006
  4. This deviceK090161 Epiphany Injection SystemStaar Surgical Co. · 2009
  5. Descendant · cites it directly · 2 of its ownK101782 Microstaar Msi Injector System CartridgeStaar Japan · 2010
  6. Descendant · 2 generations on · 0 of its ownK172375 MicroSTAAR Injector System CartridgesSTAAR Surgical Company · 2017
  7. Descendant · 2 generations on · 0 of its ownK152357 MicroSTAAR Injector System CartridgesSTAAR Surgical Company · 2015

Most influential descendants

Showing 3 of 3 · See all
  • K101782Microstaar Msi Injector System CartridgeStaar Japan · 2010 · cites it directly2descendants
  • K172375MicroSTAAR Injector System CartridgesSTAAR Surgical Company · 2017 · 2 generations on0descendants
  • K152357MicroSTAAR Injector System CartridgesSTAAR Surgical Company · 2015 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K914311Chiroflex II Lens Microsert (TM)Chiron Ophthalmics1992—
−2K970727Mport Foldable Lens Placement SystemChiron Vision Corp.19971
−1K052651C-Flex System Single Use Disposable Injector, Model R-Inj-02Rayner Surgical, Inc.2006—
0 (this device)K090161Epiphany Injection SystemStaar Surgical Co.2009—
+1K101782Microstaar Msi Injector System CartridgeStaar Japan2010—
+2K172375MicroSTAAR Injector System CartridgesSTAAR Surgical Company2017—
+2K152357MicroSTAAR Injector System CartridgesSTAAR Surgical Company2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510
200010
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201510
201710
FIG. 1 — Lineage of K090161, 1992–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 MSS? 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 MSS device

  1. #1 K261174 RxSight® Insertion Devicescore 15.1 · 13 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K052651C-Flex System Single Use Disposable Injector, Model R-Inj-02
Summary page 1
…Epiphany Injector System The primary devices used for comparison in this summary are Rayner Surgical, Inc.'s R- INJ-02 Single Use DisposableInjector (K05265 1), Chiron Vision Corp.'s MportTM Foldable Lens Placement System (K970727), Pharmacia & Upjohn's EASYSERT IntraocularLens Injector…
Rayner Surgical, Inc.2006—
*K970727Mport Foldable Lens Placement System
Summary page 1
…comparison in this summary are Rayner Surgical, Inc.'s R- INJ-02 Single Use DisposableInjector (K05265 1), Chiron Vision Corp.'s MportTM Foldable Lens Placement System (K970727), Pharmacia & Upjohn's EASYSERT IntraocularLens Injector (K002556), and STAAR Surgical Company's MicroSTAAR MSI Injector System (…
Chiron Vision Corp.19971
*K002556Ceeon Easysert Intraocular Lens Injector, Model Imp-1
Summary page 1
…Single Use DisposableInjector (K05265 1), Chiron Vision Corp.'s MportTM Foldable Lens Placement System (K970727), Pharmacia & Upjohn's EASYSERT IntraocularLens Injector (K002556), and STAAR Surgical Company's MicroSTAAR MSI Injector System (K940593, K954600, and K07359 1). 1. Intended Use: The Epiphan…
Pharmacia & Upjohn Co.2000—
*K940593Disposable Microstaar Injector
Summary page 1
…Foldable Lens Placement System (K970727), Pharmacia & Upjohn's EASYSERT IntraocularLens Injector (K002556), and STAAR Surgical Company's MicroSTAAR MSI Injector System (K940593, K954600, and K07359 1). 1. Intended Use: The Epiphany Injector System is a device intended to fold and insert STAAR Surg…
Staar Sugical19941
*K954600Microstaar Injector Models Msi-TD & Msi-PD (Modification)
Summary page 1
…Lens Placement System (K970727), Pharmacia & Upjohn's EASYSERT IntraocularLens Injector (K002556), and STAAR Surgical Company's MicroSTAAR MSI Injector System (K940593, K954600, and K07359 1). 1. Intended Use: The Epiphany Injector System is a device intended to fold and insert STAAR Surgical Comp…
Staar Surgical Co.1995—
*K073591Microstaar Msi Injector Foam Tip System
Summary page 1
…nt System (K970727), Pharmacia & Upjohn's EASYSERT IntraocularLens Injector (K002556), and STAAR Surgical Company's MicroSTAAR MSI Injector System (K940593, K954600, and K07359 1). 1. Intended Use: The Epiphany Injector System is a device intended to fold and insert STAAR Surgical Company aspheric t…
Staar Surgical Co.2008—

Also cleared against K052651: 1 other device →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K101782Microstaar Msi Injector System CartridgeStaar Japan20102

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 17 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
  • 2 of the 7 ancestors have a recall of any class.
  • Of its descendants, K101782 (Staar Japan, 2010) has gone furthest, with 2 descendants of its own.
  • 1 other device also cites its predicate K052651.

How does its category compare?

All MSS devices

MSS Folders And Injectors, Intraocular Lens (Iol): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · MSS

1in 2025

2007: 22008: 52009: 52010: 22011: 22012: 22013: 52014: 52015: 32016: 22017: 32018: 12019: 32020: 22021: 12023: 32024: 12025: 12026 (partial year): 1
2007high 5 (2008) · low 0 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MSS

54in 2023

2008: 84 days median2009: 197 days median2013: 141 days median2014: 78 days median2015: 156 days median2017: 30 days median2019: 67 days median2023: 54 days median
2007high 197 (2009) · low 30 (2017)2026

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

Recalls per year · MSS

1in 2017

2016: 12017: 1
2007high 1 (2016) · low 0 (2007)2026

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

Adverse event reports per year · MSS

429in 2025

2007: 4452008: 1852009: 1862010: 2032011: 952012: 1292013: 2032014: 1142015: 1272016: 1122017: 1142018: 3402019: 2712020: 3622021: 2892022: 4902023: 3302024: 3752025: 429
2007high 490 (2022) · low 95 (2011)2025

MAUDE reports naming product code MSS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—0445
20085840185
200951970186
20102—0203
20112—095
20122—0129
201351410203
20145780114
201531560127
20162—1112
20173301114
20181—0340
20193670271
20202—0362
20211—0289
20220—0490
20233540330
20241—0375
20251—0429
20261—0—

What is it indicated for?

The Epiphany Injector System is a device intended to fold and insert STAAR Surgical Company aspheric three piece Collamer®, Model CQ2015A, and aspheric three piece silicone intraocular lenses, Model AQ2015A, for surgical placement in the human eye.

Indications for use as stated in the FDA summary.

Also cleared against K052651

1 other device cites the same predicate.

  • K062612Rayner Single Use Soft Tipped Disposable Injector, Model R-Inj-04Rayner Surgical, Inc. · 2006

More from Staar Surgical Co.

56 FDA decisions under this applicant name. See the company

  • P880091/S032Silicon UV-Absorbing Posterior Chamber IolStaar Surgical Co. · 2010
  • P880091/S030Staar Surgical Elastic/Elastimide/Elastic Toric/Aspheric Elastimide Ultraviolet Absorbing Posterior Chamber…Staar Surgical Co. · 2009
  • P880091/S029Staar Surgical Elastic/Elastimide/Elastic Toric/Aspheric Elastimide Ultraviolet Absorbing Posterior Chamber…Staar Surgical Co. · 2009
  • P880091/S028Staar Surgical Elastic/Elastimide & Elastic Toric Ultraviolet Absorbing Posterior Chamber Intraocular LensesStaar Surgical Co. · 2008
  • P880091/S027Staar Surgical Elastic/Elastimide/Elastic Toric Ultraviolet Absorbing Posterior Chamber Intraocular LensesStaar Surgical Co. · 2008

Recent decisions in MSS

The MSS category page

  • K261174RxSight® Insertion DeviceRxsight, Inc. · 2026
  • K252540ACCUJECT Injector Set 2.1-1P (LP604590)Medicel AG · 2025
  • K242389EyeGility™ Inserter for Preloaded enVista IOLsBausch & Lomb, Incorporated · 2024
  • K231106Accuject Refra Injector AR2900Medicel AG · 2023
  • K231838RxSight® Insertion Device (63002)Rxsight, Inc. · 2023

https://510kreport.com/device/K090161 · printed Nov 4, 2026

Cite this page

510(k) Report. “K090161: Epiphany Injection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090161

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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