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510(k) Data Aggregation
K Number
K132042Device Name
AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND
Manufacturer
X6D, LTD.
Date Cleared
2014-04-28
(300 days)
Product Code
HOY
Regulation Number
886.4750Why did this record match?
Product Code :
HOY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Amblyz™ System is an electronic shutter module intended to provide occlusions of the eye in an intermittent fashion.
Device Description
The Amblyz™ device is an optical eyewear using a Liquid Crystal lens and electronics technology that acts as an intermittent shutter. The shutter incorporated in the optical lens performs an occlusion of the sound eye in an intermittent mode by changing the lens from a clear to an opaque state via electronic control. The system incorporates the following components: Spectacle Frame, Liquid Crystal Shutter (LCS), Earpieces, Nose Piece, Clip to Hold Refractive Lens, Micro-USB Connector, LED Indicator, ON/OFF Switch, Programming Button, Amblyz™ onboard Software, Amblyz™ Technician Software.
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K Number
K050856Device Name
LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM
Manufacturer
OPHTHOCARE LTD.
Date Cleared
2005-05-31
(56 days)
Product Code
HOY, HQG, HQY, HQZ
Regulation Number
886.4750Why did this record match?
Product Code :
HOY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LCG (Liquid Crystal Glasses) System is an electronic shutter module intended to provide occlusions of the eye in an intermittent fashion.
Device Description
The LCG System comprises the following main components:
The Spectacles Unit (LCGU) comprised of the refractive optical lens, Liquid Crystal Module (LCM) and the electronic control that resides in the holding strap. The adjustable holding strap contains an electronic controller with an activation button (Tact Switch) and small rechargeable batteries that provide the electric power.
The Reporting and Compliance Box (RCB) is a bedside device that serves as a charger of the spectacle's batteries. In addition, it provides a means to monitor the compliance of the patient, while providing a feedback to the user, as it records the actual wear-time of the glasses, comparing it to the prescribed time.
Technician/Factory Setup Software (LCG Set) is software residing on a PC at the factory and is used for setting the LCGU performance parameters. During setup, the LCGU is connected to the PC via the RCB by means of RS232 link.
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K Number
K971465Device Name
NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS
Manufacturer
NATIONAL HEALTHCARE MFG. CORP.
Date Cleared
1997-06-04
(43 days)
Product Code
HOY, HMX, HNM, HQR, KKX
Regulation Number
886.4750Why did this record match?
Product Code :
HOY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These kits are a convenience assemblage of sterile, disposable, legally marketed medical devices intended for use by trained physicians for Healthcare Manufacturing ophthalmic surgical procedures. National Corporation does not cause or promote new intended uses for the devices within these kits.
Device Description
The National Healthcare Manufacturing custom ophthalmic procedure trays or kits are sterile, disposable, medical device convenience kits. These kits are custom to the customer, whose specifications determine the devices included in the kit.
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