Cleared Traditional

K233653 - Midfield Light Pipe

Also marketed or referenced as:
Midfield Light Pipe, 25ga (3269.M05-00) Midfield Light Pipe, 27ga (3269.M04-00)

K233653 is an FDA 510(k) clearance for Midfield Light Pipe, manufactured by Peregrine Surgical, LLC. The device is a Class 2 Ophthalmic device with product code MPA cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K233653 · Peregrine Surgical, LLC · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K233653

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.

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

Devices cleared under the same product code (MPA) and FDA review panel - the closest regulatory comparables to K233653.
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