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Found 9 results
510(k) Data Aggregation
K Number
K033799Device Name
CLINICAL LASETTE P-200
Manufacturer
CELL ROBOTICS, INC.
Date Cleared
2003-12-22
(17 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CELL ROBOTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ablation of skin for collecting capillary blood samples for subsequent analysis.
The Cell Robotic's Lasette Laser Skin Perforator is indicated for use by qualified healthcare professionals for the perforation of skin to draw capillary blood for screening purposes.
Device Description
The Cell Robotics Lasette laser skin perforator is a portable battery operated laser device. The device produces a single pulse of laser light which ablates a small hole in the patient's fingertip comparable to that produced by commonly used stainless steel blood lancets.
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K Number
K021946Device Name
CELL ROBOTICS ULTRA-LIGHT PEEL LASER SYSTEM
Manufacturer
CELL ROBOTICS, INC.
Date Cleared
2002-09-11
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CELL ROBOTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cell Robotics, Inc. Ultra-Light laser system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthamology.
Device Description
The Cell Robotics Ultra-Light Laser System is an Er: Y AG laser producing emission at a wavelength of 2940nm. The laser consists of two interconnected sections: The cabinet which houses the power supply, the cooling system and the electronics, and; the umbilical cables and the handpiece, which houses the laser.
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K Number
K983673Device Name
LASETTE
Manufacturer
CELL ROBOTICS, INC.
Date Cleared
1999-01-15
(87 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CELL ROBOTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cell Robotic's Laser Skin Perforator is indicated for use for the perforation of skin to draw capillary blood for screening purposes.
Device Description
The Cell Robotics Lasette laser skin perforator is a portable battery operated laser device. The device produces a single pulse of laser light which ablates a small hole in the patient's fingertip comparable to that produced by commonly used stainless steel blood lancets.
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K Number
K981746Device Name
CELL ROBOTICS' LASETTE
Manufacturer
CELL ROBOTICS, INC.
Date Cleared
1998-12-07
(203 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CELL ROBOTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cell Robotics Lasette Laser Skin Perforator is indicated for obtaining capillary blood samples for subsequent analysis of blood glucose concentration, in both institutional and at-home settings.
Device Description
The Cell Robotics Lasette laser skin perforator is a portable battery operated laser device. The device produces a single pulse of laser light which ablates a small hole in the patient's fingertip comparable to that produced by commonly used stainless steel blood lancets.
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K Number
K982230Device Name
LASETTE LASER SKIN PERFORATOR
Manufacturer
CELL ROBOTICS, INC.
Date Cleared
1998-09-24
(177 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CELL ROBOTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ablation of skin tissue to establish capillary blood access. The Cell Robotics Laser Skin Perforator is intended for use by qualified healthcare professionals for collecting capillary blood samples from adult patients, for subsequent determination of blood glucose concentration and hematocrit.
Device Description
The Cell Robotics Laser skin perforator is a portable battery operated laser device. The device produces a single pulse of laser light which ablates a small hole in the patient's fingertip comparable to that produced by commonly used stainless steel blood lancets.
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K Number
K981149Device Name
LASETTE LASER SKIN PERFORATOR
Manufacturer
CELL ROBOTICS, INC.
Date Cleared
1998-06-29
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CELL ROBOTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cell Robotics Lasette Laser Skin Perforator is indicated for use by qualified healthcare professionals for collecting capillary blood samples from all patients (5 years old and above) for subsequent determination of blood glucose concentration and hematocrit.
Device Description
The Cell Robotics Lasette laser skin perforator is a portable battery operated laser device. The device produces a single pulse of laser light which ablates a small hole in the patient's fingertip comparable to that produced by commonly used stainless steel blood lancets.
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K Number
K973431Device Name
LASETTE
Manufacturer
CELL ROBOTICS, INC.
Date Cleared
1997-10-28
(48 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CELL ROBOTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cell Robotics Lasette Laser Skin Perforator is intended for use by qualified healthcare professionals for collecting capillary blood samples from adult patients, for subsequent determination of blood glucose concentration and hematocrit using optically based measurement techniques.
Device Description
The Cell Robotics Lasette laser skin perforator is a portable battery operated laser device. The device produces a single pulse of laser light which ablates a small hole in the patient's fingertip comparable to that produced by commonly used stainless steel blood lancets.
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K Number
K965124Device Name
LASETTE
Manufacturer
CELL ROBOTICS, INC.
Date Cleared
1997-08-14
(234 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CELL ROBOTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cell Robotics Lasette is intended for use for skin perforation and establishing capillary blood access for blood sampling. The Cell Robotics Lasette is indicated for use by qualified healthcare workers for perforation of the skin to draw capillary blood from healthy adult patients for subsequent determination of blood glucose concentration and hematocrit using colorimetric measurements.
Device Description
The Cell Robotics Lasette laser skin perforator is a portable battery operated laser device. The device produces a single pulse of laser light which ablates a small hole in a patient's fingertip comparable to that produced by commonly used stainless steel blood lancets. The complete Lasette product includes the Lasette. its labeling and manual, and single-use sanitary (non-sterile) plastic iqns shelds. The Lasette uses a small convection-cooled erbium: YAG solid state laser with a maximum output energy of 0.5 J per pulse at a wavelength of 2.94 micrometers and a pulse width of 300 microsconds. This energy is focused on a target spot with a diameter of 300 micrometers.
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K Number
K970461Device Name
CELL ROBOTICS ER: YAG SURGICAL LASER
Manufacturer
CELL ROBOTICS, INC.
Date Cleared
1997-07-11
(155 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CELL ROBOTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cell Robotics, Inc. unnamed Er: YAG Surgical laser is indicated for use in small and large joint Arthroscopy, including microdiscectomies, endoscopic procedures and general surgical procedures for cutting (incision / excision), vaporizing and coagulation of soft tissues, including skin, subcutaneous tissue, muscle, meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
Device Description
The Cell Robotics Er:YAG Surgical Laser is an Er:YAG laser producing laser emission at 2940nm. The laser consists of three interconnected sections: The cabinet which houses the power supply, the cooling system and the microcontroller, the swing arm and the handpiece, which houses the laser.
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