MPA · Class II · 21 CFR 876.1500

FDA Product Code MPA: Endoilluminator

Leading manufacturers include Peregrine Surgical , Ltd., M.B. Industries, Inc. and American Medical Devices, Inc..

41
Total
41
Cleared
133d
Avg days
1995
Since
Stable submission activity - 2 submissions in the last 2 years
Review times increasing: avg 219d recently vs 128d historically

FDA 510(k) Cleared Endoilluminator Devices (Product Code MPA)

41 devices
1–24 of 41
Cleared Aug 10, 2026
Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)
K253468
Nova Eye, Inc.
Ophthalmic · 305d
Cleared Dec 04, 2024
Alcon 27GA Chandelier (8065000252)
K242184
Alcon Laboratories, Inc.
Ophthalmic · 132d
Cleared Aug 05, 2024
Midfield Light Pipe, 23ga (3269.M06-00)
K233653
Peregrine Surgical, LLC
Ophthalmic · 265d
Cleared Mar 30, 2023
ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System
K221872
Nova Eye Inc. (Business Name Nova Eye Medical)
Ophthalmic · 275d
Cleared Aug 20, 2021
Nam illumination probe with chopper
K202670
Oculight , Ltd.
Ophthalmic · 340d
Cleared Sep 11, 2015
23ga Chandelier Illuminator, 25ga Chandelier Illuminator
K151604
Peregrine Surgical , Ltd.
Ophthalmic · 88d
Cleared Feb 24, 2015
Synergetics PHOTON EX
K143123
Synergetics
Ophthalmic · 116d
Cleared Jul 18, 2008
ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER
K080067
Iscience Interventional
Ophthalmic · 190d
Cleared Oct 13, 2006
XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII
K062895
Dutch Ophthalmic Research Center International BV
Ophthalmic · 16d
Cleared Aug 15, 2006
ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100
K062259
Iscience Surgical
Ophthalmic · 11d
Cleared Jun 22, 2004
ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA
K041108
Iscience Surgical Corporation
Ophthalmic · 55d
Cleared Nov 24, 2003
SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
K032598
Synergetics, Inc.
Ophthalmic · 91d
Cleared May 19, 1998
PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR
K980797
Peregrine Surgical , Ltd.
Ophthalmic · 78d
Cleared May 12, 1998
PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.13
K980530
Peregrine Surgical , Ltd.
Ophthalmic · 90d
Cleared Mar 31, 1998
PEREGRINE TAPERED DIFFUSION PROBE
K980025
Peregrine Surgical , Ltd.
Ophthalmic · 85d
Cleared Mar 31, 1998
PEREGRINE SHIELDED DIFFUSION PROBE
K980027
Peregrine Surgical , Ltd.
Ophthalmic · 85d
Cleared Nov 25, 1997
D.O.R.C. HEXON ILLUMINATION SYSTEM
K973229
Dutch Ophthalmic USA, Inc.
Ophthalmic · 90d
Cleared Nov 18, 1997
SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR
K973293
Vaughan Weeks
Ophthalmic · 77d
Cleared Nov 14, 1997
SYNTEC TRUE LIGHT ENDOILLUMIINATOR WITH PICK
K973290
Vaughan Weeks
Ophthalmic · 73d
Cleared Nov 07, 1997
D.O.R.C. SOLUX LIGHT SOURCE
K973757
Dutch Ophthalmic USA, Inc.
Ophthalmic · 36d
Cleared Jun 25, 1997
I-SCOPE OPHTHALMIC ENDOSCOPE
K971679
Ophthalmic Technologies, Inc.
Ophthalmic · 49d
Cleared Jun 24, 1997
ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)
K970882
American Medical Devices, Inc.
Ophthalmic · 106d
Cleared Jun 09, 1997
SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
K964005
Synergetics, Inc.
Ophthalmic · 275d
Cleared May 20, 1997
ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)
K970875
American Medical Devices, Inc.
Ophthalmic · 71d

About Product Code MPA - Regulatory Context

510(k) Submission Activity

41 total 510(k) submissions under product code MPA since 1995, with 41 receiving FDA clearance (average review time: 133 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - MPA Product Code

Recent submissions under MPA have taken an average of 219 days to reach a decision - up from 128 days historically. Manufacturers should account for longer review timelines in current project planning.

MPA devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →