Cleared Traditional

K233653 - Midfield Light Pipe, 23ga (3269.M06-00) (FDA 510(k) Clearance)

Also includes:
Midfield Light Pipe, 25ga (3269.M05-00) Midfield Light Pipe, 27ga (3269.M04-00)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233653 · Peregrine Surgical, LLC · Ophthalmic device
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Aug 2024
Decision
265d
Days
Class 2
Risk

K233653 is an FDA 510(k) clearance for the Midfield Light Pipe, 23ga (3269.M06-00). Classified as Endoilluminator (product code MPA), Class II - Special Controls.

Submitted by Peregrine Surgical, LLC (New Britain, US). The FDA issued a Cleared decision on August 5, 2024 after a review of 265 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Peregrine Surgical, LLC devices

Submission Details

510(k) Number K233653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2023
Decision Date August 05, 2024
Days to Decision 265 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 110d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.