Cleared Special

K132614 - PEREGRINE CURVED ILLUMINATING LASER PROBE (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K132614 · Peregrine Surgical , Ltd. · Ophthalmic device
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Nov 2013
Decision
85d
Days
Class 2
Risk

K132614 is an FDA 510(k) clearance for the PEREGRINE CURVED ILLUMINATING LASER PROBE. Classified as Photocoagulator And Accessories (product code HQB), Class II - Special Controls.

Submitted by Peregrine Surgical , Ltd. (New Britain, US). The FDA issued a Cleared decision on November 14, 2013 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4690 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Peregrine Surgical , Ltd. devices

Submission Details

510(k) Number K132614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2013
Decision Date November 14, 2013
Days to Decision 85 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 110d · This submission: 85d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HQB Photocoagulator And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4690
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 - HQB Photocoagulator And Accessories

All 29
Devices cleared under the same product code (HQB) and FDA review panel - the closest regulatory comparables to K132614.
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