Atlas FDA

KYB

39 FDA 510(k) clearances · Product code

87 daysmedian time to decision
241 days90th percentile
39clearances measured

FDA profile

Official device name
Lens, Guide, Intraocular
Device class
Class I (low risk)
Regulation
21 CFR 886.4300
Medical specialty
Ophthalmic
Adverse events (MAUDE)
2021: 349 · 2022: 294 · 2023: 304 · 2024: 416 · 2025: 433 · 2026: 201
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
MicroSTAAR Injector System Cartridges (K152357)STAAR Surgical Company2015-10-30
DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 (K081382)Duckworth & Kent, Ltd.2008-10-23
DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 (K072985)Duckworth & Kent, Ltd.2008-06-20
IOL INJECTOR SET (K070669)Medicel AG2007-11-01
MONARCH III IOL DELIVERY SYSTEM (K063155)Alcon Manufacturing, Ltd.2007-03-27
AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 (K063694)Bausch & Lomb, Inc.2007-03-07
RE-USEABLE MICROSTAAR INJECTOR, MSI-S (K032412)Staar Surgical Co.2004-06-10
MASTEL 1 FOLDER IMPLANTATION SYSTEM (K022723)Mastel Precision, Inc.2002-12-26
MONARCH II IOL DELIVERY SYSTEM (K001157)Alcon Research, Ltd.2000-06-27
DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) (K983129)Staar Surgical Co.1998-12-04
MONARCH IOL DELIVERY SYSTEM (K981571)Alcon Laboratories1998-07-09
MONARCH IOL DELIVERY SYSTEM (K970033)Alcon Laboratories1997-04-23
ACRYPAK FOLDER (K965185)Alcon Laboratories1997-03-31
AMO PHACOFLEX II INTERSECTION SYSTEM (K961242)Allergan, Inc.1996-06-17
MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION) (K954600)Staar Surgical Co.1995-12-21
PASSPORT FOLDABLE LENS PLACEMENT SYSTEM (K951292)Chiron Vision Corp.1995-06-02
KLAAS IOL LENSFOLDER (K930628)Bova Intl.1995-02-07
DISPOSABLE MICROSTAAR INJECTOR (K940593)Staar Sugical1994-09-19
AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE (K941603)Allergan Medical Optics1994-07-06
AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR (K930320)Allergan Medical Optics1994-04-07
CHIROFLEX FORCEPS (K903575)Chiron Ophthalmics1990-12-21
CHIROFLEX LENS MICROSERT (K903574)Chiron Ophthalmics1990-09-17
KRATZ NOVA SERT(TM) (K883489)Coopervision-Cilco1988-10-25
KRATZ NOVA-SERT (K871440)CooperVision, Inc.1987-05-07
KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR (K870265)CooperVision, Inc.1987-02-20
SOFT LENS FOLDER (K861990)Staar Surgical Co.1986-06-17
ELASTIC LENS INJECTOR TM (K861085)Staar Surgical Co.1986-05-28
MAZZOCCO/FRENCHIK FOLDER (K860148)Staar Surgical Co.1986-03-21
BARTELL SMALL INCISION LENS GLIDE (K854994)Microtech, Inc.1986-02-04
IOSERT LENS IMPLANT INSTRUMENT (K854197)Chiron Vision Corp.1986-01-22
BAILEY LENS SHOOTER (K841730)Intermedics Intraocular, Inc.1984-11-19
LENS INSERTION GLIDE (K840694)Innovative Surgical Products, Inc.1984-05-09
PETRUS IOL GUIDE (K840104)Precision-Cosmet Co., Inc.1984-04-24
I-GLIDE IOL IMPLANTATION AID (K832939)I For M, Inc.1983-10-04
INTRAOCULAR LENS GUIDE (K823222)American Medical Optics1982-12-28
IOL FORCEPS (K821381)Cilco, Inc.1982-06-14
SURFACE REPLACEMENT HIP PROSTHESIS (K811718)Biomet, Inc.1981-09-18
M.P.I. LENS GLIDE (K792066)J. Leon Bilby1980-01-29
CEMENT SPACERS (K791351)Depuy, Inc.1979-08-03

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