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Found 14 results
510(k) Data Aggregation
K Number
K973354Device Name
SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)
Manufacturer
SHARPLAN LASERS, INC.
Date Cleared
1997-12-04
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SHARPLAN LASERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sharplan Model 5000 Alexandrite Laser System is intended for use in dermatology for the removal of dark, unwanted body hair.
Device Description
The Sharplan Model Alexandrite Laser System is a medical device which capable of emitting an invisible pulsed treatment laser beam at a wavelength of 755 nm under the guidance of a visible aiming beam. This laser can be utilized in either the continuous or timed exposure modes of operation.
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K Number
K972099Device Name
SHARPLAN EPITOUCH RUBY LASER SYSTEM
Manufacturer
SHARPLAN LASERS, INC.
Date Cleared
1997-08-27
(84 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SHARPLAN LASERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sharplan Ruby Laser System, with its fiber delivery system, is intended for use in dermatology for the removal of unwanted body hair.
Device Description
The Sharplan Ruby Laser System is a surgical laser which is capable of providing pulsed laser energy of a 694.3 nm wavelength in the free running mode through an optical fiber beam delivery system. While observing and directing the aiming beam (633 nm, HeNe), the treatment beam is administered by the physician through a foot switch.
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K Number
K971874Device Name
SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)
Manufacturer
SHARPLAN LASERS, INC.
Date Cleared
1997-08-18
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SHARPLAN LASERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sharplan Model 5000 Alexandrite Surgical Laser System is intended for use in dermatology for the treatment of vascular lesions.
Device Description
The Sharplan Model Alexandrite Laser System is a medical device which capable of emitting an invisible pulsed treatment laser beam at a wavelength of 755 nm under the guidance of a visible aiming beam. This laser can be utilized in either the continuous or timed exposure modes of operation
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K Number
K971648Device Name
SHARPLAN ERBIUM: YAG LASER (4020)
Manufacturer
SHARPLAN LASERS, INC.
Date Cleared
1997-07-23
(79 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SHARPLAN LASERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sharplan Model 4020 Erbium:YAG Surgical Laser System is intended for incision/excision, ablation, vaporization, and/or coagulation of soft-tissue in-Plastion-Surgery/Dermatology.
Device Description
The Sharplan Model 4020 Erbium YAG Surgical Laser is a medical device which capable of emitting an invisible pulsed treatment laser beam at a wavelength of 2.94 u under the guidance of an visible aiming beam. This laser can be utilized in either the continuous or timed exposure modes of operation
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K Number
K971743Device Name
SHARPLAN CO2 SURGICAL LASER SYSTEM
Manufacturer
SHARPLAN LASERS, INC.
Date Cleared
1997-07-18
(67 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SHARPLAN LASERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sharplan 15F CO2 Laser System is intended for use as a heat source to activate tooth bleaching materials.
Device Description
The Sharplan Model 15F CO2 Surgical Laser is a medical device which is capable of being used as a heat source for activating tooth bleaching materials. It emits a treatment laser beam at a wavelength of 10.6 um up to 15 watts in either continuous or pulse wave modes of operation.
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K Number
K962446Device Name
SHARPLAN RUBY LASER SYSTEM
Manufacturer
SHARPLAN LASERS, INC.
Date Cleared
1997-03-07
(256 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SHARPLAN LASERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is intended for use in dermatology for the removal of unwanted dark body hair.
Device Description
The Sharplan Ruby Laser System is a surgical laser which is capable of providing pulsed (O-Switched or Free Running) laser energy of a 694.3 nm wavelength through an articulated arm beam delivery system. While observing and directing the aiming beam (633 nm, HeNe), the treatment beam is administered by the physician through a foot switch.
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K Number
K963229Device Name
SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS
Manufacturer
SHARPLAN LASERS, INC.
Date Cleared
1996-11-05
(78 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SHARPLAN LASERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sharplan Models 20c, 30c, and 40c (for this indication) are substantially equivalent to the following devices: The Sharplan CO2 Lasers which are intended for use in ENT and the ScalpelTEC, Inc. Myringotomy Safety Scalpel. They are intended for soft tissue incision in ENT for the specific indication of Myringotomy/Tympanostomy.
Device Description
The Sharplan Models 20c, 30c, and 40c CO2 Lasers are surgical lasers are medical devices which capable of incising soft tissue. They emit a treatment laser beam at a wavelength of 10.6 um up to 40 watts and a 3 mWatt HeNe aiming beam.
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K Number
K961935Device Name
SHARPLAN LASERS, INC. SILKTOUCH CO2 FLASH SCANNER
Manufacturer
SHARPLAN LASERS, INC.
Date Cleared
1996-11-01
(165 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SHARPLAN LASERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is indicated for soft tissue incision of recipient sites for laser assisted hair transplantation.
Device Description
The Sharplan Lasers, Inc. SilkTouch CO2 Flash Scanner Accessory is a motorized, laser beam deflection system that is attached to a CO2 laser articulating arm. The device redirects a focused laser beam through moving mirrors, within a specified pattern scan area. Similar to the common surgeon's technique of manually scanning a focused beam over a treatment area, the constantly moving beam of the SilkTouch Flash Scanner limits the time of laser exposure on tissue while providing sufficient power density for tissue vaporization at low average power levels The SilkTouch Flash Scanner has controls for varying the scanned area setting the exposure time. This device is used with a CO2 handpiece. When the unit is turned off, the connected laser operates to its specifications and allows incision or manual scanning for vaporization purposes.
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K Number
K962974Device Name
SHARPLAN LASERS, INC. AF ACUSPOT MICROMANIPULATOR (713)
Manufacturer
SHARPLAN LASERS, INC.
Date Cleared
1996-08-21
(21 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SHARPLAN LASERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sharplan Model 713 AF Acuspot Micromanipulator is substantially equivalent to the following devices: The Sharplan Model 712 Micromanipulator, the Reliant UniMax Model 2000, and the Heraeus LaserSonics Ultraspot Micromanipulator. It is indicated for incision, excision, coagulation, ablation, and vaporization of soft tissue, to be used with compatible, legally marketed surgical lasers.
Device Description
The Sharplan Model 713 AF Acuspot Micromanipulator is an accessory for a CO2 Surgical Laser. It attaches to the distal end of an articulated arm and connects to a surgical microscope. Its purpose is to allow a physician the ability to focus and steer laser beams so that when tissue is visualized, it can be selectively treated.
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K Number
K961279Device Name
SHARPLAN LASERS, INC. RUBY LASER SYSTEM
Manufacturer
SHARPLAN LASERS, INC.
Date Cleared
1996-06-18
(76 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SHARPLAN LASERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is intended for use in dermatology for photothermolysis, for the specific indications {in adults (18 years or older)} to remove blue-black tattoos, or to remove or lighten benign epidermal pigmented lesions.
Device Description
The Sharplan Ruby Laser System is a surgical laser which is capable of providing pulsed laser energy of a 694.3 nm wavelength through an articulated arm beam delivery system. While observing and directing the aiming beam (633 nm, HeNe), the treatment beam is administered by the physician through a foot switch.
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