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510(k) Data Aggregation
K Number
K202038Device Name
CryoTreQ
Manufacturer
VitreQ B.V.
Date Cleared
2020-12-30
(160 days)
Product Code
HPS, CLA
Regulation Number
886.4170Why did this record match?
Applicant Name (Manufacturer) :
VitreQ B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VitreQ CryoTreQ is indicated for use in ophthalmic surgery for retinal detachment, cyclodestructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, cryodestruction of lash follicles for trichiasis and the treatment of retinopathy of prematurity (ROP).
Device Description
The VitreQ CryoTreQ is a disposable, handheld instrument intended for use in ophthalmic cryotherapy. The device tip is made of stainless steel. The device utilizes a pressurized cryogen which is circulated to the tip. The cryogenic material remains enclosed within the tip during application, serving to cool the metal tip during therapy. Rapid gas expansion in the tip causes freezing to the Joule-Thompson principle.
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K Number
K182646Device Name
Vitreq disposable laser probes, light fibers and Chandelier
Manufacturer
Vitreq B.V.
Date Cleared
2019-05-01
(219 days)
Product Code
HQB, HQF, MPA
Regulation Number
886.4690Why did this record match?
Applicant Name (Manufacturer) :
Vitreq B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VitreQ Disposable Laser Probes, 90° Directional Laser Probes and 90° Directional Illuminated Laser Probes are intended for use in vitreoretinal surgery to perform endo-ocular laser photocoagulation treatments at operating wavelengths of 500nm to 900nm.
The 90° Directional Illuminated Laser Probes, Light Fibers and Chandelier are for illumination during ophthalmic surgery and should only be used with the light wavelength range of 425nm to 700mm.
Device Description
The VitreQ Disposable Laser Probe is an ophthalmic instrument, which is used in posterior segment eye surgery and is appropriate for photocoagulation. The device can be connected to an ophthalmic laser generator, which is not a part of this application.
The VitreQ Disposable Laser Probe is introduced into the posterior segment of the eye through an incision or an ophthalmic entry port, after the vitreous is removed during vitreoretinal surgery.
The Disposable Laser Probe guides the laser energy to the intended surgical site to provide photocoagulation treatment. The laser enerqy intensity or power output is not controlled, altered or significantly reduced by the disposable laser probe. The laser spot size on the target tissue can be varied by altering the distance between the tissue and the probe tip.
To reach the target tissue in the periphery section of the 90° Directional Laser Probe tip can be directed due to bending the metal tip. The angle of the tip in the most directed position is about 90°. An angled laser probe reduces the need of a strong indentation of the eye and is intended to prevent accidently touching the crystal lens.
The VitreQ Disposable Laser Probes, 90° Directional Laser Probes and (90°) Directional Illuminated Laser Probes are constructed with an optical laser connector, a glass fiber optic covered by a protective sheath and one handle for surgeon manipulation, metal tubing is extending from the handle which penetrates the surgical site. The device is intended for singleuse only.
The VitreQ Disposable Laser Probes can only be used with a medical laser at an operating wavelength range of 500nm to 900nm.
For the VitreQ Disposable Laser Probes, (90°) Directional Illuminated Laser Probe the functionality is combined with illumination. To achieve the illumination of the surgical site, the probe is constructed with an additional plastic fiber, which has a connector to attach the fiber to an ophthalmic light source, which is not a part of this application.
The VitreQ Disposable Light Fibers are constructed with a handle, the plastic illumination fiber, and the connector to attach the fiber to an ophthalmic light source. To match the connection to the ophthalmic light source, there are several reusable light source adaptors available.
The VitreQ (90°) Directional Illuminated Laser Probes, Light Fibers and Chandelier can only be used with the light wavelength range of 425nm to 700nm.
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