Cleared Traditional

K041108 - ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA

K041108 is an FDA 510(k) clearance for ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA, manufactured by Iscience Surgical Corporation. The device is a Class 2 Ophthalmic device with product code MPA cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K041108 · Iscience Surgical Corporation · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
55d
Days
Class 2
Risk

K041108 is an FDA 510(k) clearance for the ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA. Classified as Endoilluminator (product code MPA), Class II - Special Controls.

Submitted by Iscience Surgical Corporation (Irvine, US). The FDA issued a Cleared decision on June 22, 2004 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 876.1500 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K041108

510(k) Number K041108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2004
Decision Date June 22, 2004
Days to Decision 55 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 110d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MPA Device Classification - Class 2, Special Controls

Product Code MPA Endoilluminator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - MPA Endoilluminator

All 40
Devices cleared under the same product code (MPA) and FDA review panel - the closest regulatory comparables to K041108.
ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER
K080067 · Iscience Interventional · Jul 2008
XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII
K062895 · Dutch Ophthalmic Research Center International BV · Oct 2006
ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100
K062259 · Iscience Surgical · Aug 2006
SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
K032598 · Synergetics, Inc. · Nov 2003
INSIGHT 4000 ENDOSCOPE
K000252 · Insight Instruments Mfg., Inc. · Oct 2000
TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001
K000416 · Retinalabs.Com · May 2000
K041108 · ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA
Download PDF FDA Summary Iscience Surgical Cor…