Atlas FDA

HQE

149 FDA 510(k) clearances · Product code

86 daysmedian time to decision
210 days90th percentile
149clearances measured

FDA profile

Official device name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.4150
Medical specialty
Ophthalmic
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 32 · 2022: 46 · 2023: 108 · 2024: 105 · 2025: 341 · 2026: 180
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
UniVit HE, UniVit UHS (K212763)Visioncare Devices, LLC2022-08-10
Cetus system, Cetus probe (K170183)A.R.C Laser GmbH2017-09-27
Bi-Blade Vitrectomy Cutter (K153168)Medical Instrument Development Laboratories2016-04-29
CONSTELLATION VISION SYSTEM (K141065)Alcon Research, Ltd.2014-08-22
VERSAVIT (K121675)Synergetics, Inc.2012-06-21
PROCARE PLUS VITRECTOMY SYSTEM (K120170)Visioncare Devices, Inc.2012-05-30
ULTIMATE VIT ENHAMCER (UVE) (K102222)Medical Instrument Development Laboratories, Inc.2011-04-08
COLIBRI DISPOSABLE VITRECTOMY CUTTER (K033390)Microworld Medical Instruments, Inc.2003-11-04
VMATE MODEL VMM1000 (K030948)Howard Instruments, Inc.2003-06-17
VELOCITY ADVANTAGE (K023939)Visioncare Devices, Inc.2003-04-17
MID LABS AUTONOMOUS VIT ENHANCER (AVE) (K020911)Medical Instrument Development Laboratories, Inc.2002-04-29
D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM (K010082)Dutch Ophthalmic USA, Inc.2001-03-12
VIT ENHANCER (K992943)Medical Instrument Development Laboratories, Inc.1999-12-10
I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN (K990292)Ophthalmic Consultants, Inc.1999-11-19
D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM (K983797)Dutch Ophthalmic USA, Inc.1999-03-03
PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10 (K980400)Peregrine Surgical , Ltd.1998-04-30
PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20 (K980399)Peregrine Surgical , Ltd.1998-04-30
STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM (K980488)Storz Instrument Co.1998-03-23
REUSABLE VITRECTOMY PROBE (K970670)Altex Vision1997-05-06
DISPOSABLE VITRECTOMY PROBE (K970673)Altex Vision1997-05-05
STORZ E8010 ERGOTEC/PREMIERE ADAPTOR (K964743)Storz Instrument Co.1997-02-03
VIT COMMANDER SYSTEM (K961738)Scieran Technologies, Inc.1996-11-25
STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE (K960061)Storz Instrument Co.1996-09-18
AUTOMATED VITRECTOMY DEVICE (K961078)Promex, Inc.1996-06-14
STORZ DP4800 DELUXE , STORZ DP4801 BASIC W/REFLUX, DP4801 BASIC POSTERIOR VITRECTOMY PACK WITH VARIABLE PORT CUTTER & RX (K954816)Storz Instrument Co.1996-03-04
STORZ MVS-3201 VITRECTOMY PROBE PACK (K953575)Storz Instrument Co.1995-09-14
STORZ DP4505 VITREOUS MEMBRANE DISSECTOR (K953576)Storz Instrument Co.1995-09-14
CUTTER, VITREOUS ANTERIOR VITRECTOMY PROBE (AVP) (K950852)H.S. Intl. Co., Inc.1995-05-19
PRO-VIT (K950799)M. Imonti and Associates Inc.,1995-04-28
INFINITECH ASPIRATING LASER PROBE (K946135)Surgical Technologies, Inc.1995-04-18
INFINITECH SOFT TIP FLUTE NEEDLE (K946181)Surgical Technologies, Inc.1995-03-14
MICRODRIVE (K934600)Medical Instrument Development Laboratories, Inc.1994-07-27
NIDEK MODEL VT-4000, MODIFICATION (K936302)Nidek, Inc.1994-07-15
PEREGRINE REVERSE CUTTING KNIFE LIGHT PIPE (K940391)Peregrine Surgical , Ltd.1994-06-08
VIT CUTTER MODEL 94 (K940746)Visioncare Devices, Inc.1994-06-06
SUPRA-VIT(TM) (K932669)Medical Instrument Development Laboratories, Inc.1994-06-03
THE GRIESHABER SYST/AI TUBING SET AND CARTRIDGE (K930842)Grieshaber & Co.1994-05-03
STORZ FIBEROPTIC PICK MANIPULATOR (K933907)Storz Instrument Co.1994-03-07
OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER (K932668)Synergetics, Inc.1994-02-23
INTERTIP INFUSION SET (K934204)Oasis Medical, Inc.1994-02-07
STORZ FIBEROPTIC REVERSE CUTTING KNIFE (K933984)Storz Instrument Co.1994-01-25
BARE-FIBER ENDOILLUMINATOR (K933208)Surgical Technologies, Inc.1993-12-14
NIDEK MODEL VST-4000 (K924353)Nidek, Inc.1993-03-29
MID LABS, INC. VIT MATE (K924222)Medical Instrument Development Laboratories, Inc.1993-01-27
STORZ REUS 20/25 GAUGE VITRE CUT W/REUS HAND/DRIV (K924604)Storz Instrument Co.1992-11-27
POLLY'S VITREOUS SCISSORS J-225-S (K922355)O.R. Specialties, Inc.1992-08-18
STORZ PROTEGE OPTHALMIC MICROSURGICAL SYSTEM (K921758)Storz Instrument Co.1992-07-16
STORZ PREMIERE/PREMIERE MICROVIT MICROSURG SYSTEMS (K921460)Storz Instrument Co.1992-07-02
DISPOSABLE POSTERIOR MICROSCISSORS (K920718)Storz Instrument Co.1992-05-18
180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT. (K920582)Site Microsurgical Systems, Inc.1992-05-08
D7113 ANVIL CUTTER AND D7112 AIR-POWERED HANDLE (K915745)Storz Instrument Co.1992-03-13
STORZ MICRO CUTTER 25 GAUGE PACK (K913504)Storz1992-02-21
DWYER EYE SYSTEMS ASPIRATION UNIT (K913261)Spectracare, Inc.1992-01-30
DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE (K912384)Nidek, Inc.1991-12-24
POLLY'S CUTTER J-225 (K914038)O.R. Specialties, Inc.1991-12-09
MICROSCIS(TM) INTROCULAR SCISSOR SYSTEM (K913837)Vision Medical, Inc.1991-11-05
KPE 220 TS, NONSTERILE (K914221)Ipax, Inc.1991-10-25
LANDERS 3 STRUT IRRIGATING VITRECTOMY LENS RING (K912253)Ocular Instruments, Inc.1991-08-07
MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM (K911998)Allergan Medical Optics1991-07-26
DISPOSABLE IRRIGATING/ASPIRATING HANDPIECE (K910973)Surgical Technologies, Inc.1991-04-26
I/A VITROPHAGE MODEL YPR 2001 (K904909)Visioncare Devices, Inc.1991-01-28
GLAUCOMA MECHANICAL TREPHINE (K895813)Trek Medical Products, Inc.1990-04-30
SITE DISPOSABLE CUTTER AND ACCESSORIES (K896943)Site Microsurgical Systems, Inc.1990-03-08
CONVERTER SYSTEM (K894248)Mira, Inc.1990-02-27
I/A HANDPIECE (K896754)Advanced Surgical Products, Inc.1990-01-11
MULTI-USE I/A HANDPIECE (K896305)Advanced Surgical Products, Inc.1989-12-18
STORZ DAISYPLUS SERIES MICROSURGICAL SYSTEMS (K894278)Storz Instrument Co.1989-08-11
JAMES SURGICAL SYSTEM J1000 (K890195)O.R. Specialties, Inc.1989-08-03
POWER OPERATED AND CONTROLLED VITREOUS SCISSORS (K891601)Mira, Inc.1989-05-23
ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE (K884557)Advanced Surgical Products, Inc.1989-05-12
SURG-E-TROL SYSTEM I AND SYSTEM II (K890622)Mentor O & O, Inc.1989-05-04
INTERCASSETTE, INTERKIT, UNIVERSAL PAK & CASSETTE (K890300)CooperVision, Inc.1989-04-17
OCULAR CONNECTION MACHINE(TM) (K890133)Innovision Medical, Inc.1989-04-12
DREYER CURVED ENDOILLUMINATOR (K884556)Advanced Surgical Products, Inc.1989-02-28
SHAPIRO CUTTER (K890544)H.S. Intl. Co., Inc.1989-02-28
LASER INDIRECT OPHTHALMOSCOPE (LIO) (K885196)Coherent Medical Group1989-01-11
GRIESHABER MICRO LITE LIGHT PIPE 19 & 20 GAUGE (K884043)Grieshaber & Co.1988-11-16
.2MM, .4MM, .5MM IRRIGATION AND ASPIRATION HAND. (K883926)Site Microsurgical Systems, Inc.1988-11-15
DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI. (K883975)Site Microsurgical Systems, Inc.1988-10-25
MODIFIED REUSABLE SITE FIBER OPTIC CABLE (K883605)Site Microsurgical Systems, Inc.1988-10-25
VAC-G (GUILLOTINE VITRECTOR) (K881519)B&B Medical Assoc., Inc.1988-09-08
VAC (OSCILLATING VITRECTOR) (K881520)B&B Medical Assoc., Inc.1988-09-07
MICROLINE CAT #100 (K880943)Microline Pentax, Inc.1988-05-26
PRISMA TECH 19 GAUGE DISPOSABLE EXTRUSION NEEDLES (K881927)Advanced Surgical Products, Inc.1988-05-25
NIDEK CV-4000 (K880929)Nidek, Inc.1988-05-25
MODEL 2001 PHACOEMULSIFIER ASPIRATOR (K880968)Mcghan Instrumed Corp.1988-04-19
MODEL 3000 OPHTHALMIC SURGICAL SYSTEM (K872312)Allergan Humphrey1987-07-15
SERIES TEN THOUSAND OCUTOME (K871871)CooperVision, Inc.1987-06-11
SITE PERISTALTIC MODULE SYSTEM (K871375)Site Microsurgical Systems, Inc.1987-05-07
ENTRAVISION MODECO II VITREOUS CUTTING HANDPIECE (K870775)Entravision, Inc.1987-03-26
ASPIRATION REVERSAL CONTROL (ARC) MODULE (K870068)Optical Micro Systems, Inc.1987-02-12
VES-10 INTRAOCULAR SCISSORS DRIVE (K864035)Trek Medical Products, Inc.1986-12-15
SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE (K862943)Site Microsurgical Systems, Inc.1986-08-21
IRRIGATION & ASPIRATION/VITRECTOMY DEVICE (K862188)Coburn Optical Ind., Inc.1986-08-21
SERIES TEN THOUSAND MASTER (K861380)CooperVision, Inc.1986-07-11
SERIES TEN THOUSAND COMPACT (K861565)CooperVision, Inc.1986-07-11
VACUUM HANDLE MODEL I/A - 1 (K862343)Cutler Medical Instruments1986-07-11
AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE (K860891)Intra-Optics Labs. C/O Newman Assoc.1986-04-21
SYSTEMS PLUS (K860014)United Surgical Corp.1986-03-05
VIT PAC (K834162)American Surgical Co., Inc.1986-02-07
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