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510(k) Data Aggregation
K Number
K142984Device Name
Leo Minor
Manufacturer
SUNNEX, INC.
Date Cleared
2014-10-29
(13 days)
Product Code
FSY
Regulation Number
878.4580Why did this record match?
Product Code :
FSY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Leo Minor is intended to provide visible illumination of the surgical field and the patient during surgical and non surgical procedures.
Device Description
Not Found
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K Number
K142076Device Name
CLAVEGUARD FREEDOM SURGICAL LIGHT
Manufacturer
DICKSON & DICKSON HEALTHCARE (US), INC
Date Cleared
2014-09-30
(61 days)
Product Code
FSY
Regulation Number
878.4580Why did this record match?
Product Code :
FSY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Claveguard Freedom Surgical Light is designed to illuminate the surgical site in Operating theatres
Device Description
The ClaveGuard Freedom surgical lights are suitable for all types of surgical procedures in operating rooms. The light is based on Light Emitting Diodes (LEDs) in combination with adaptive focus and shadow free illumination. It operates at a distance of 70-140cm from the surgical site. A light system may consist of 1 to 3 light heads supported by pivoting suspension system that is mounted to Healthcare facility's ceiling. The system may include optional monitor extension arms, monitor mounts, and in-light video camera.
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K Number
K140812Device Name
MI-750 PROCEDURAL/MINOR SURGICAL LIGHT
Manufacturer
MEDICAL ILLUMINATION INTERNATIONAL, INC.
Date Cleared
2014-08-07
(128 days)
Product Code
FSY
Regulation Number
878.4580Why did this record match?
Product Code :
FSY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MI-750 is a fixed pattern / three level intensity procedural/minor surgical light designed to provide visible illumination of the surgical field and the patient during minor surgical and non-surgical procedures.
Device Description
The proposed MI-750 is a first generation fix pattern / three level intensity procedural/minor surgical light designed to provide visible illumination of the surgical field and the patient during minor surgical and non-surgical procedures.
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K Number
K132551Device Name
ZF 720
Manufacturer
UMBEL CORPORATION
Date Cleared
2014-06-30
(320 days)
Product Code
FSY
Regulation Number
878.4580Why did this record match?
Product Code :
FSY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Shadowless Operation Light ZF 720 is intended to be used to provide visible illumination of the surgical area or the patient with high intensity and shadow free light during surgical procedures.
Device Description
The Surgical Light ZF 720 is applicable for Open surgery, Endoscope surgery or other surgical procedures. With ceiling, wall and floor versions, the Surgical Light ZF 720 Systems are well-suited for various operating rooms. The device can be adjusted the color temperature, light intensity and light focus in accordance with the different visual habit by the users. And it is workable to connect to the monitor, video or other expansion devices with the requirements of the surgical environment. The Surgical Light ZF 720 consists of base assembly, pendent system and light head assembly integrated into one system. The Surgical Light ZF 720 provides optimum shadow resolution and ease of maneuverability. And the extension arm on the central block possesses the movement mechanism which enables the light heads swivel in all directions. With ceiling, wall and floor versions, the Surgical Light ZF 720 is well-suited for various operating rooms. It is also available in single, dual and triple configurations in compliance with users' requirements. The software is equipped in the device. Dispense with training before using the device.
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K Number
K140930Device Name
VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES
Manufacturer
CONVIDA HEALTHCARE & SYSTEMS CORPORATION
Date Cleared
2014-06-09
(59 days)
Product Code
FSY
Regulation Number
878.4580Why did this record match?
Product Code :
FSY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VIDA LED Surgical Lighting System, V series provide illumination for surgery or examination at operating room.
Device Description
The VIDA LED Surgical Lighting System, V series provide illumination for surgery or examination at operating room.
VIDA LED Surgical Lighting System, V series uses high-efficacy light-emitting-diodes (LED) as light source which provides high brightness and no extra heat; the design of the optical mechanism gives a characteristic of less shadow which is significant to the surgeon during the operation. Given of its modular design, VIDA V provided many options for configurations and can be installed in an operating room with or without a laminar air flow system.
The features of VIDA LED Surgical Lighting System, V series are as followed:
- Prism-Based Light Delivery Technology: ConVida's patented optical system, that . combines an advanced refractive prism lens and innovative high-power LED technology, focuses light into an intense 110cm (43") focal cylinder, eliminating the need for refocusing when adjusting surgical table.
- . Consistent Illumination at Different Color Temperature Settings: VIDA V series lighthead's color temperature can be individually adjusted at any of the 5 settings (3500K, 4000K, 4250K, 4500K, 5000K) with a high CRI of 95, R9 94.
- . Optimal Brightness without Glare: Elegant, sophisticated optical system consists up to 2 types of high-power LEDs and multiple refractive prisms produces up to 160,000 lux of intensity without discomfort flare/glare.
- . VIDA V light gives the Surgeon Control: On the VIDA V, both lighthead focus and light intensity can easily be adjusted via turning the lighthead handle. They are also adjustable from the standard lighthead control or optional VIDA V Control Center on the wall.
- Long Lifetime: Under normal use, VIDA V LEDs enjoy an extremely long lifetime of . 50,000+ hours (70% lumen maintenance at 50,000 hours).
- . Two Types of Ambient Lights (Option): 5% central luminance (GUIDE lighting mode) c be configured through standard lighthead control. Guide lighting mode may ambient lighting for manipulating endoscopy instruments or lighting diagnos procedures. Green ambient light sheds low-level green light from the suspension hub
- Camera-Ready Lighthead is Built into the System: All VIDA V lightheads are pre-wired . with HD cabling for taking an optional HD 1080p Camera Handle. The HD 1080p Camera Handle is removable from one VIDA V lighthead to another providing superb flexibility for recording.
- Exceptional Maneuvering Flexibility: The exceptionally durable non-sterile handles allow easy positioning of all our lightheads. Each lighthead rotates a full 360°so that the system can be quickly and easily positioned for any surgical procedure. Individual lightheads can be lower to 810mm above the floor providing excellent low lateral illumination.
- . Sleek Non-Sterile Handle: The lighthead has is molded with a sleek all-around handle that facilitates easy repositioning and adds modern elegance to O.R. setting
- Easy-to-clean Compact Lighthead: Made of tough molded materials, the VIDA V series . lightheads are completely sealed which helps prevent biocontaminants from entering the operative site and lighthead itself, and facilitates cleaning.
- . HD Supported Suspensions: All VIDA V suspensions are prewired with video cables to deliver information users need within and without the surgical field. Images are in crisp and accurate HD format with no signal conversion necessary and no loss of video quality.
- Heavy Duty HD Flat Monitor Suspension: Flat Monitor Suspension Arms support single/dual monitors up to a total of 24 kg (53 lbs), making them ideal for surgical displays up to 32". Large display compatibility allows the surgical team to see more of the procedural area. Optional Medical Grade LCD Displays from SONY also offer uncompressed HD video at 1080p which shows true images from SD- and HD-endoscopes, ultrasound, C-arms and other equipment.
- Optimal HD Connectivity: The built-in fiber optic cable allows the suspension to support monitors featuring Full HD 1920 x 1080 video signals.
- . Low Profile Suspension: Low-profile cardinal lighthead suspension is offered for rooms with ceiling lower than 280mm.
- . Failsafe Design: The unit is protected against an electrical power failure, thus ensuring that all surgical procedures can continue without interruption.
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K Number
K140460Device Name
MACH LED 2SC
Manufacturer
DR. MACH GMBH & CO. KG
Date Cleared
2014-04-03
(38 days)
Product Code
FSY
Regulation Number
878.4580Why did this record match?
Product Code :
FSY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The surgical light Mach LED 2SC is intended to illuminate the surgical field and the patient.
Device Description
The surgical light Mach LED 2SC is intended to illuminate the surgical field and the patient.
The Mach LED 2SC consists of lamp housing, LED modules, optical -/electrical and mechanical components, one sterilizable handle sleeve as well as the cables.
One LED-module consists of one white LED.
The light system can be added to the ceiling mounted suspension system supporting the horizontal arms and spring arms. The horizontal arms can be rotated horizontally with 360°, the spring arms can be rotated horizontally with 360° and moved vertically with 50° downwards and 45° upwards.
The light system is operated by a kevpad on the lamp head or, by special request of the customer, by a keypad on the wall.
The surgical light Mach LED 2SC will be marketed with merging of light fields and light intensity control. Color temperature adjustment will not be available.
Available accessories for the Mach LED 2SC lighting systems are as follows:
- Camera module .
- Remote control of camera module .
- Remote control with network interface for camera module .
- Single monitor yoke for flat panel monitors .
- Double monitor yoke for flat panel monitors .
- Instrument trays .
- Trays for CRT monitors
- 24V DC battery backup support .
- . Low profile wall control unit
- Integrated laser pointer .
- Sterilizable handle sleeves
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K Number
K140461Device Name
MACH LED 2MC
Manufacturer
DR. MACH GMBH & CO. KG
Date Cleared
2014-04-03
(38 days)
Product Code
FSY
Regulation Number
878.4580Why did this record match?
Product Code :
FSY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The surgical light Mach LED 2MC is intended to illuminate the on the patient's body with a high intensity, shadow-free and "cold" light.
The Mach LED 2MC lighting system is designed for illuminating an examination area and surgical field at the hospital and doctor's practice.
Device Description
The surgical light Mach LED 2MC is intended to illuminate the operation site on the patient's body with a high intensity, shadow free and "cold" light.
The Mach LED 2MC consists of lamp housing, LED modules, optical, electrical and mechanical components, one sterilizable handle sleeve as well as the cables.
One LED-module consists of 4 different-colored LEDs: warm white, cold white, green and red. The four different colors are merged inside the lamp head by a computercalculated optical system with light guide and facetted lenses.
The light system can be added to the ceiling mounted suspension system supporting the horizontal arms and spring arms. The horizontal arms can be rotated horizontally with 360°, the spring arms can be rotated horizontally with 360° and moved vertically with 50° downwards and 45° upwards.
The light system is operated by a keypad on the lamp head or, by special request of the customer, by a keypad on the wall.
The surgical light Mach LED 2MC will be marketed with merging of light fields, light intensity control, color temperature adjustment and integrated laser pointer.
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K Number
K132747Device Name
VISUM BLADE LED SURGICAL LIGHTING SYSTEM
Manufacturer
STRYKER COMMUNICATIONS
Date Cleared
2013-12-30
(118 days)
Product Code
FSY
Regulation Number
878.4580Why did this record match?
Product Code :
FSY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Visum Blade LED Surgical Light is intended to illuminate the operative site during surgical procedures with high intensity light.
The Visum Blade LED Surgical Light System is indicated to be used with various mounting configurations in operating rooms, examination rooms, emergency rooms, and all other health care facilities where the need for additional illumination exists.
Device Description
The Visum Blade LED Surgical Light System (Blade) is suitable for all major and minor surgical procedures in operating rooms and all other healthcare facilities where the need for illumination exists. The light intensity is variable up to 160,000 Lux. The light quality is based upon high quality LED's to provide cool light with reduced shadow resolution.
A system consists of 1 - 4 light heads supported by a pivoting suspension system that is attached to the heath care facility's super structure by a mounting plate. The system requires at least one of the following: a power supply box, ceiling cover, drop tube, central axis and spring arm. The system may include optional end effectors such as but not limited to monitor mounts. The mounting plates may be configured to accommodate a single or tandem mount suspension system.
Independent, control of each light's intensity is via the light handle. An optional electronic wall control panel may be installed in the operating room for control by non-sterile users. Blade allows for an in-light camera option that may be added to a light head. This option requires a wall control for camera operation.
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K Number
K132307Device Name
VIDA LED SURGICAL LIGHTING SYSTEM
Manufacturer
CONVIDA HEALTHCARE & SYSTEMS CORPORATION
Date Cleared
2013-11-05
(104 days)
Product Code
FSY
Regulation Number
878.4580Why did this record match?
Product Code :
FSY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VIDA LED Surgical Lighting System - X series provide illumination for surgery or examination at operating room.
Device Description
The VIDA LED Surgical Lighting System-X series provide illumination for surgery or examination at operating room. The VIDA LED Surgical Lighting System-X series (VIDA X) use high-efficacy light-emitting diodes (LED) for surgical operations and diagnostic purposes. LEDs provide bright and shadow reduced light. Thanks to its modular design. VIDA X also offers many options for configurations and can be installed in operating rooms with or without laminar air flow systems. A lighthead to the main spindle can be rotated horizontally with 360°. the spring arms can be rotated horizontally with 360° and moved vertically with 45° downwards and 30° upwards. The VIDA LED Surgical Lighting System-X series consists of Mounting Module, Horizontal Arm module, Suspension Device Module, sterile handle cover and Optional Accessories.
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K Number
K131893Device Name
AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS
Manufacturer
AJW TECHNOLOGY CONSULTANTS, INC.
Date Cleared
2013-10-30
(127 days)
Product Code
FSY
Regulation Number
878.4580Why did this record match?
Product Code :
FSY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Amico iCE LED series surgical lights are to provide high intensity, shadow free illumination to the patient surgical field during surgical procedures.
The intended use of the Amico Mira LED series minor surgery lights is to provide high intensity, shadow free illumination to the patient surgical field during minor surgery procedures.
Device Description
Amico iCE series consists of 3 models - iCE-30-6, iCE-25-6, & iCE-25-3. These are major surgical luminaires that provide illumination in a surgical suite allowing doctors to operate on a patient.. The device comes with several built-in fail safe's preventing any single fault from creating a hazardous situation. These lamps are a Class 2 device (under FDA) providing max illumination of 160,000 lx, 160.0001x, and 130.000 Ix respectively. These surgical lights are coupled with ceiling mounted suspension systems supporting horizontally articulating extensions arms and horizontally and vertically articulating spring arms. Both arms can rotate either 340 degree (with stop) or infinitely without a stop. The spring arms vertically articulate 50° downwards and 45° upwards. This allows for ease of movement of the lamp head to any given position. The lamp housing is made of high quality plastic wrapped around an aluminum structure. The front clear glass is made of high quality polycarbonate material. The yoke connecting the lamp head to the spring arms is made of steel. The lamps also have a built-in mechanical focusing system that is controlled using the center Aluminum and/or plastic handle. Rotating this handle allows the user to expand and contract the lighted field as per the user's requirement. The lamps can also be sold with an optional in-light camera that doubles as a focusing handle. This provides the user with the option to record/display small areas of a surgical site on a large display allowing for greater detail and accuracy during surgeries. A separate remote control is used to control the various functions of the camera.
Amico Mira LED series consists of 3 models - Mira LED 90, Mira LED 65 & Mira LED 50. These are minor surgical luminaires that provide illumination in a surgical suite allowing doctors to perform minor surgical procedures on a patient. These lamps are a Class 2 device (under FDA) providing max illumination of 90.000 1x. 65.000 Ix, and 50.000 Ix respectively. These surgical lights are coupled with ceiling mounted suspension systems supporting horizontally articulating extensions arms and horizontally and vertically articulating spring arms. Both arms can rotate either 340 degree (with stop) or infinitely without a stop. The spring arms vertically articulate 50° downwards and 45° upwards. This allows for ease of movement of the lamp head to any given position. The lamp housing is made of high quality plastic which connects to the front clear glass is made of high quality polycarbonate material. The yoke connecting the lamp head to the spring arms is made of steel. The lamps also have a built-in electronic focusing system that is controlled using the center Aluminum/plastic handle. Rotating this handle allows the user to expand and contract the lighted field as per the user's requirement.
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