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23GA Curved Illuminating Laser Probe

FDA 510(k)

Class II (US FDA 510(k))

510(k) K122997

by Peregrine Surgical , Ltd.

Identifiers

510(k) Number
K122997 FDA 510(k)
FDA Product Code
HQB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.4690 FDA 510(k)
Regulation Number
886.4690 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The 23GA Curved Illuminating Laser Probe is a photocoagulator accessory designed for ophthalmic use. It combines illumination and laser delivery in a curved, 23-gauge probe, enabling precise retinal procedures such as photocoagulation, vitrectomy, or membrane ablation.

This device is supplied sterile and intended for single-use in controlled surgical environments. It is classified as a Class II medical device under FDA regulations, with a special 510(k) clearance for ophthalmic applications. The curved design facilitates access to retinal structures, and its 23-gauge size ensures compatibility with standard vitreoretinal instrumentation.

Frequently asked questions

What types of retinal procedures is this laser probe specifically designed to assist with?

This 23GA Curved Illuminating Laser Probe is designed for precise retinal procedures such as photocoagulation, vitrectomy, and membrane ablation. Its curved 23-gauge design allows for better access to retinal structures, making it particularly useful in ophthalmic surgeries where illumination and laser delivery are required.

Is this device reusable or intended for single-use, and how is it supplied?

The 23GA Curved Illuminating Laser Probe is intended for single-use only and is supplied sterile. This ensures safety and reliability in controlled surgical environments, reducing the risk of contamination or cross-infection between patients.

What size and design features make this probe compatible with standard vitreoretinal instruments?

The probe is a 23-gauge design, which aligns with standard vitreoretinal instrumentation. Its curved shape enhances maneuverability, allowing surgeons to reach and treat specific retinal areas more effectively during procedures like photocoagulation or membrane ablation.

How should this device be stored, and what precautions should be taken?

Since the probe is supplied sterile, it should be stored in its original packaging until ready for use. The packaging should remain unopened and protected from contamination, moisture, or physical damage. Always follow manufacturer guidelines for storage conditions to maintain sterility and functionality.

What regulatory pathway was followed for this device’s approval, and what does that mean for its use?

This device received FDA 510(k) clearance under a Special 510(k) pathway, classified as a Class II medical device for ophthalmic applications. The clearance confirms it is substantially equivalent to a predicate device, ensuring it meets FDA safety and performance standards for photocoagulation accessories in controlled surgical settings.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Laser Probes — Peregrine Surgical - Ophthalmic and Vitreoretinal ..., Peregrine Surgical - Ophthalmic and Vitreoretinal Surgical Instruments, 23GA CURVED ILLUMINATING LASER PROBE - Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Peregrine Surgical , Ltd.

Sources (1)

  • FDA 510(k) K122997 24 fields · synced Sep 19, 2026