Cleared Special

K122997 - 23GA CURVED ILLUMINATING LASER PROBE

K122997 is an FDA 510(k) clearance for 23GA CURVED ILLUMINATING LASER PROBE, manufactured by Peregrine Surgical , Ltd.. The device is a Class 2 Ophthalmic device with product code HQB cleared through the Special 510(k) pathway after a 272-day FDA review.

K122997 · Peregrine Surgical , Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
272d
Days
Class 2
Risk

K122997 is an FDA 510(k) clearance for the 23GA 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 June 26, 2013 after a review of 272 days - an extended review 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. Standard predicate reliance. 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

FDA 510(k) Submission Details - K122997

510(k) Number K122997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2012
Decision Date June 26, 2013
Days to Decision 272 days
Submission Type Special
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
162d slower than avg
Panel avg: 110d · This submission: 272d
Pathway characteristics
Modification to existing cleared device.

HQB Device Classification - Class 2, Special Controls

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 24
Devices cleared under the same product code (HQB) and FDA review panel - the closest regulatory comparables to K122997.
MAXReach Laser Probe
K191846 · Vortex Surgical, Inc. · Dec 2019
Vitreq disposable laser probes, light fibers and Chandelier
K182646 · Vitreq BV · May 2019
PEREGRINE CURVED ILLUMINATING LASER PROBE
K132614 · Peregrine Surgical , Ltd. · Nov 2013
PEREGRINE 23GA CURVED LASER PROBE
K122905 · Peregrine Surgical , Ltd. · Apr 2013
SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE
K113857 · Synergetics, Inc. · Apr 2012
27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA
K110951 · Alcon Research, Ltd. · Oct 2011