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Endoilluminator

FDA product code MPA · 39 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.1500
Review panel: OP
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1995-09-01 – 2026-08-10

MPA 2026-08-10

Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)

Applicant Nova Eye, Inc.

K number K253468

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MPA 2024-12-04

Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);

Applicant Alcon Laboratories, Inc.

K number K242184

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MPA 2024-08-05

Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)

Applicant Peregrine Surgical, LLC

K number K233653

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MPA 2023-03-30

ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System

Applicant Nova Eye Inc. (Business Name Nova Eye Medical)

K number K221872

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MPA 2021-08-20

Nam illumination probe with chopper

Applicant Oculight , Ltd.

K number K202670

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MPA 2008-07-18

ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER

Applicant Iscience Interventional

K number K080067

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MPA 2006-10-13

XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII

Applicant Dutch Ophthalmic Research Center International BV

K number K062895

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MPA 2006-08-15

ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100

Applicant Iscience Surgical

K number K062259

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MPA 2004-06-22

ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA

Applicant Iscience Surgical Corporation

K number K041108

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MPA 2003-11-24

SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE

Applicant Synergetics, Inc.

K number K032598

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MPA 2000-10-17

INSIGHT 4000 ENDOSCOPE

Applicant Insight Instruments Mfg., Inc.

K number K000252

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MPA 2000-05-08

TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001

Applicant Retinalabs.Com

K number K000416

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MPA 1998-05-19

PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR

Applicant Peregrine Surgical , Ltd.

K number K980797

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MPA 1998-05-12

PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.13

Applicant Peregrine Surgical , Ltd.

K number K980530

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MPA 1998-03-31

PEREGRINE SHIELDED DIFFUSION PROBE

Applicant Peregrine Surgical , Ltd.

K number K980027

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MPA 1998-03-31

PEREGRINE TAPERED DIFFUSION PROBE

Applicant Peregrine Surgical , Ltd.

K number K980025

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MPA 1997-11-25

D.O.R.C. HEXON ILLUMINATION SYSTEM

Applicant Dutch Ophthalmic USA, Inc.

K number K973229

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MPA 1997-11-18

SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR

Applicant Vaughan Weeks

K number K973293

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MPA 1997-11-14

SYNTEC TRUE LIGHT ENDOILLUMIINATOR WITH PICK

Applicant Vaughan Weeks

K number K973290

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MPA 1997-11-07

D.O.R.C. SOLUX LIGHT SOURCE

Applicant Dutch Ophthalmic USA, Inc.

K number K973757

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MPA 1997-06-25

I-SCOPE OPHTHALMIC ENDOSCOPE

Applicant Ophthalmic Technologies, Inc.

K number K971679

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MPA 1997-06-24

ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)

Applicant American Medical Devices, Inc.

K number K970882

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MPA 1997-06-09

SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE

Applicant Synergetics, Inc.

K number K964005

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MPA 1997-05-20

ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)

Applicant American Medical Devices, Inc.

K number K970875

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MPA 1997-05-13

MBI CO-AXIAL ILLUMINATED RETINAL PICK

Applicant M.B. Industries, Inc.

K number K964553

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MPA 1997-05-13

MBI ILLUMINATED RETINAL PICK

Applicant M.B. Industries, Inc.

K number K964405

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MPA 1997-05-06

SYNTEC, INC. DISPOSABLE BARE END FIBER

Applicant Syntec, Inc.

K number K971338

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MPA 1997-05-06

ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT

Applicant American Medical Devices, Inc.

K number K970878

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MPA 1997-03-31

VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S)

Applicant Vitrotec, Inc.

K number K964555

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MPA 1996-12-20

VITLITE (TR7700)

Applicant Escalon Trek Medical

K number K963417

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MPA 1996-07-15

MBI FIBEROPTIC ENDO-ILLUMINATOR

Applicant M.B. Industries, Inc.

K number K961036

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MPA 1996-03-26

STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR

Applicant Storz

K number K960007

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MPA 1996-01-05

GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATOR

Applicant Gamp & Assoc.

K number K952585

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MPA 1996-01-05

GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC VISCOINJECTOR

Applicant Gamp & Assoc.

K number K952581

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MPA 1995-10-19

INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEM

Applicant Infinitech, Inc.

K number K951627

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MPA 1995-10-02

INFINITECH LIGHTED INFUSION CANNULA

Applicant Surgical Technologies, Inc.

K number K946136

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MPA 1995-09-01

GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC ENDOILLUMINATOR

Applicant Gamp & Assoc.

K number K952586

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MPA 1995-09-01

GAMP & ASSOCIATES DISPOSABLE ENDOILLUMINATOR W/PICK

Applicant Gamp & Assoc.

K number K952584

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MPA 1995-09-01

GAMP & ASSOCIATES DISPOSABLE BARE END FIBER

Applicant Gamp & Assoc.

K number K952580

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