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510(k) Data Aggregation
K Number
K051486Device Name
NORWOOD ABBEY CENTURION SES EPIKERATOME
Manufacturer
NORWOOD ABBEY , LTD.
Date Cleared
2005-07-06
(30 days)
Product Code
HNO
Regulation Number
886.4370Why did this record match?
Applicant Name (Manufacturer) :
NORWOOD ABBEY , LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Norwood Abbey Centurion SES Epikeratome is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea.
Device Description
The Norwood Abbey Centurion SES Epikeratome is an AC-powered device that is used by incising the epithelium at a predetermined location and diameter using a high-speed oscillating separator made of PMMA. The device consists of the following main components and accessories: console, separator drive assembly, suction ring assembly (with 10.0 and 9.0mm suction franquece, separator anve assombly, oaction ing are may as embly (accessory), forceps and an epithelial separator. The Norwood Abbey Centurion SES Epikeratome contains a Head Unit Assembly (with The Norwood Abbey Container sizes) that allows the cornea to protrude through the ഴിയ വിവിധ വാടിനിന് caction is suspended from the end of the separator drive assembly housing that is moved by a drive mechanism along a forward path inside the suction ring nousing that is moved by a unve mechannel and vacuum for the suction ring are provided by user command via the console and foot pedal.
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K Number
K042810Device Name
CENTURION SES EPIKERATOME
Manufacturer
NORWOOD ABBEY , LTD.
Date Cleared
2004-10-28
(16 days)
Product Code
HNO
Regulation Number
886.4370Why did this record match?
Applicant Name (Manufacturer) :
NORWOOD ABBEY , LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Norwood Abbey Centurion SES Epikeratome is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea, and for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.
Device Description
The Norwood Abbey Centurion SES Epikeratome is an AC-powered device that is used for making a separation or flap by incising the epithelium at a predetermined location and diameter using a high-speed oscillating separator made of PMMA. The device consists of the following main components and accessories: the drive control unit (DCU), handpiece, separator drive assembly, suction positioning ring assembly (now with 10.0 and 9.0mm sizes), a foot pedal, a tubing set with fluid collection assembly (accessory), and an epithelial separator.
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K Number
K033962Device Name
LAD (EPITURE EASYTOUCH), MODEL LAD-08
Manufacturer
NORWOOD ABBEY , LTD.
Date Cleared
2004-02-20
(60 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
NORWOOD ABBEY , LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LAD-08 is indicated for ablation of the outer layer of the skin prior to the application of OTC topical 4% lidocaine cream, for local dermal anesthesia.
Device Description
The Norwood Abbey Model LAD-08 is a portable, handheld, battery powered bern hismater The Norwood Abbey Model LAD-60 is a portuois, handelength of 2.94 um and a beam diameter of I he radiant energy produced by thin itsel mas a m. spot-size of 6 mm at the treatment site. The radiation delivered by the device is sufficient to remove the stratum corneum of skin exposed to the treatment.
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K Number
K021222Device Name
LAD, MODEL LAD-01
Manufacturer
NORWOOD ABBEY , LTD.
Date Cleared
2003-01-08
(266 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
NORWOOD ABBEY , LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LAD device is indicated for the rapid production of local dermal anesthesia using topical OTC lidocaine 4%.
The LAD is indicated for the ablation of the outer layer of the skin prior to the application of OTC topical 4% lidocaine cream, for local dermal anesthesia.
Device Description
The Norwood Abbey Model LAD-01 is a portable, battery powered, single pulse Er: Y AG laser. The radiant energy produced by this laser has a wavelength of 2.94 um, duration of approximately 300 us, and a beam diameter or spot-size of 3 mm at the treatment site. The radiation delivered by the device is sufficient to remove the stratum corneum of skin exposed to the treatment.
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