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510(k) Data Aggregation
K Number
K200911Device Name
MIRA Adapter
Manufacturer
Phakos
Date Cleared
2020-06-02
(57 days)
Product Code
HRN
Regulation Number
886.4170Why did this record match?
Product Code :
HRN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PHAKOS Disposable Retinal Cryo Probe and Accessories is for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, and cryo destruction of lash follicles for trichiasis.
Device Description
The cryoprobe ADAPTER is a mechanical accessory used to adapt the PHAKOS Disposable Retinal Cryo Probe to different cryosurgery generators found on the market; it is connected to the cryoprobe connector on the generator. The rear end piece receiving the cryoprobe is the same for all ADAPTERs; the body varies according to the generator used. The ADAPTER is fitted on the generator in the place of the original cryoprobe, and remains in position, while the PHAKOS Disposable Retinal Cryo Probe is plugged into the universal rear end piece.
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K Number
K180195Device Name
Frigitronics adapter
Manufacturer
Phakos
Date Cleared
2018-03-16
(51 days)
Product Code
HRN
Regulation Number
886.4170Why did this record match?
Product Code :
HRN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PHAKOS Disposable Retinal Cryo Probe and Accessories is for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, and cryo destruction of lash follicles for trichiasis.
Device Description
The cryoprobe adapter is a mechanical accessory used to adapt the PHAKOS Disposable Retinal Cryo Probe to different cryosurgery generators found on the market; it is connected to the cryoprobe connector on the generator. The rear end piece receiving the cryoprobe is the same for all adapters; the body varies according to the generator used. The adapter is fitted on the generator in the place of the original cryoprobe, and remains in position, while the PHAKOS Disposable Retinal Cryo Probe is plugged into the universal rear end piece.
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K Number
K162756Device Name
PHAKOS Disposable Retinal Cryo Probe
Manufacturer
PHAKOS
Date Cleared
2017-05-03
(215 days)
Product Code
HRN
Regulation Number
886.4170Why did this record match?
Product Code :
HRN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PHAKOS Disposable Retinal Cryo Probe is for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataraction, and cryo destruction of lash follicles for trichiasis.
Device Description
The PHAKOS Disposable Retinal Cryo Probe is a single use item used with cryopexy equipment. It produces an ice ball at the tip of the pencil allowing you to treat the detachment of the retina by welding the tissues together. The ice ball is the result of a specific gas released at a high pressure, N2O or CO2, allowing the welding of the tissues by burn.
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K Number
K160591Device Name
D.O.R.C. Disposable Cryo Probe
Manufacturer
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV
Date Cleared
2017-01-23
(328 days)
Product Code
HRN
Regulation Number
886.4170Why did this record match?
Product Code :
HRN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The D.O.R.C. Disposable Cryo Probe is intended for use in combination with the Cryostar Cryosurgical System to perform ophthalmic surgery of the posterior segments including cryopexy for retinal detachment, glaucoma, cataract extraction, trichiasis, and retionopathy of prematurity.
Device Description
The D.O.R.C. Disposable Cryo Probe is a single-use, handheld medical device intended for use in combination with the Cryostar Cryosurgical System to perform ophthalmic surgery. When the foot pedal of the CryoStar Console is pressed, high pressure gas (CO2 or N2O) is supplied via a small aperture to target tissue.
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K Number
K131787Device Name
CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES
Manufacturer
KEELER LTD.
Date Cleared
2013-12-23
(188 days)
Product Code
HRN, REV
Regulation Number
886.4170Why did this record match?
Product Code :
HRN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Keeler Cryomatic System and probes are for use in ophthalmic surgery such as cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, cryo destruction of lash follicles for trichiasis and treatment of retinopathy of prematurity (ROP).
Device Description
The Cryomatic MKII console is a self-contained system. The console consists of a rigid PU enclosure, housing the principle subsystems, switch mode power supply, controller PCB and pneumatic control module. On the front of the console is an LCD screen and membrane key panel. The console provides the connection point for the range of probe (reusable and disposable), footswitch, mains electricity, gas supply and scavenging system.
There is a variety of Keeler Re-usable Cryomatic Probes whose stainless tips are shaped depending on surgical application. The plastic handle is permanently connected to flexible pressure hose and integral connector, which connects to Cryomatic MKII Console.
The Keeler Disposable Cryo Probe comprises a stainless steel stem with a metal handle connected to a 2m long bi-lumen high-pressure plastic hose contained within a protective outer tube and terminated with a customdesigned plastic connector for insertion into the Cryomatic MKII console.
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K Number
K112093Device Name
CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER
Manufacturer
KEELER INSTRUMENTS, INC.
Date Cleared
2011-12-08
(139 days)
Product Code
HRN
Regulation Number
886.4170Why did this record match?
Product Code :
HRN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K062412Device Name
CRYOMATIC
Manufacturer
KEELER INSTRUMENTS, INC.
Date Cleared
2006-11-06
(81 days)
Product Code
HRN
Regulation Number
886.4170Why did this record match?
Product Code :
HRN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Keeler Cryomatic System and probes are for use in ophthalmic surgery in cryopexy procedures in refractory glaucoma, for retinal detachment, cryo destruction, cataract extraction, cryo destruction of lash follicles, extraction of fragments within the eye, and treatment of retinopathy of prematurity (ROP).
Device Description
Cryomatic System and Probes comprising of: a) Cryomatic Console b) Cryomatic Probes
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K Number
K012821Device Name
D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM
Manufacturer
DUTCH OPHTHALMIC USA, INC.
Date Cleared
2001-10-22
(60 days)
Product Code
HRN
Regulation Number
886.4170Why did this record match?
Product Code :
HRN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The D.O.R.C. Harmony CryoStar Cryosurgical System is a surgical system for ophthalmic surgery intended for use in surgery of the posterior segment or anterior segment including cryopexy for retinal detachment, glaucoma, cataract extraction, trichiasis, and retinopathy of prematurity.
Device Description
The D.O.R.C. CryoStar Cryosurgical System consists of a cryogen gas bottle, a console, an ophthalmic probe, a footswitch and necessary interconnections. The console controls delivery of the gas to the probe. It also processes signals from the footswitch, enabling the probe to freeze and defrost.
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K Number
K992954Device Name
KEELER CRYO MASTER & PROBES
Manufacturer
KEELER INSTRUMENTS, INC.
Date Cleared
1999-12-21
(111 days)
Product Code
HRN
Regulation Number
886.4170Why did this record match?
Product Code :
HRN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Keeler CryoMaster & Probes are for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, cryo destruction of lash follicles for trichiasis, and treatment of retinopathy of prematurity (ROP).
Device Description
Not Found
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