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510(k) Data Aggregation
K Number
K052604Device Name
STARLITE 2006
Manufacturer
LASER DENTAL INNOVATIONS
Date Cleared
2005-12-16
(86 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
LASER DENTAL INNOVATIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Starlite 2006 will be used with the following lasers for the excision, ablation, vaporization and hemostasis of soft tissue.
Diolase ST produced by American Dental Technologies (810 Nm operating wavelength) Twilight produced by Biolase (810 Nm operating wavelength) Diodent produced by Hoya Con Bio (810 Nm operating wavelength) Softlase produced by Zap Lasers (810 Nm operating wavelength) Aurora produced by Premier Lasers (810 Nm operating wavelength)
indications of use summary statement: The StarLite laser fiber optic can be used for all the of the lasers cited above as well as other diode soft tissue lasers operating using the same wavelengths.
The StarLite will become an intergral part of the laser system and by default be cleared for the same exact indications and procedures as the laser it is deployed on.
Device Description
The starLite 2065 is an "after-market" accessory for use with an existing surgical laser system. The device is used as a complete system (optical fiber and connector) The StarLite 2006 IS used as a direct replacement for the laser optical fiber supplied as original equipment or the original equipment laser optical fiber.
One of the primary considerations when using a fiber-optically delivered surgical laser system is that the fiber is capable of delivering the maximum amount of energy the laser is set for minus a small connector loss.
Most fiber based laser systems include a handpiece that clasps or grips the laser fiber on its protective jacket. For this reason the laser fiber must have an outside coating capable of protecting the inner core.
Many procedures call for the use or application of a "bare fiber" to the operative tissue; the so called "contact mode" of operation.
The StarLice is designed using industry standard connectors and optical fiber. The components of this fiber optic assembly are the same as what is currently being used on cleared existing lasers cited above. The protective outside buffer or jacket is compatible with all handpieces designed for this fiber type.
The starLite laser fiber optic is intended for use with lasers that do various surgical procedures. The StarLite is universal in nature and is intended to be used on currently FDA cleared soft tissue lasers. The StarLite assembly is designed to accommodate hard clad faser fibers including 200, 300, 400 and 600 micron diameters.
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K Number
K993942Device Name
LITESABER 2000
Manufacturer
LASER DENTAL INNOVATIONS
Date Cleared
2000-01-18
(60 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
LASER DENTAL INNOVATIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lite Saber™ 2000 indications for use are for the cleared indications for the laser system to which it is attached. For example, dermatological, ENT, general surgery, GYN surgery, oral/dental, maxillofacial, orthopaedic and podiatric procedures for the incision, excision, ablation, vaporization and hemostasis of soft tissue.
Device Description
The Licesaber™ 2000 is an "after-market" accessory for use with an existing surgical laser system. The device may be used as a complete system (handpiece and tips) or just the tips may be used with an existing handpiece of the ultradent style. The LiceSaber™ 2000 is used as a direct replacement for the laser handpiece supplied as original equipment or the original equipment laser handpiece tip. The Licesaber™ 2000 is designed address the need to direct the beam in a direction other than straight through the handpiece. Further, it does so without the need for refractive or reflective contact tips. The Licesaber 2000 gently and effectively clasps the clad fiber while bending the distal bare fiber into a smooth radius. Pre-curved disposable tips channel the fiber. Precurved tips are available. The directional tips may be rotated 360 degrees. This allows the laser fiber to be directed laterally, up, down or any angle or radius in between. The tips are disposable and the handpiece is reusable.
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