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Found 12 results
510(k) Data Aggregation
K Number
K992013Device Name
DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER
Manufacturer
CONTINUUM BIOMEDICAL, INC.
Date Cleared
1999-09-08
(85 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CONTINUUM BIOMEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For Removal of Caries and for Cavity Preparation in Primary and Secondary Teeth.
Device Description
DeL2940 Dental Erbium Laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench. Delivery is via fiber optic with a quartz contact tip. At 10 pulses per second an a pulse energy of 1 Joules, the average power from the laser is 10 watts.
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K Number
K983054Device Name
MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND: YAG LASER
Manufacturer
CONTINUUM BIOMEDICAL, INC.
Date Cleared
1999-02-10
(162 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CONTINUUM BIOMEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the removal or lightening of unwanted hair without adjuvant preparation
For the removal or lightening of unwanted hair in the 1064nm mode only without adjuvant preparation using one or two treatments.
Device Description
Medlite™ Q-Switched Nd:YAG Laser
Medlite™ IV Q-Switched Nd:YAG Laser
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K Number
K973719Device Name
MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YAG LASER
Manufacturer
CONTINUUM BIOMEDICAL, INC.
Date Cleared
1997-12-23
(84 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CONTINUUM BIOMEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the removal or lightening of unwanted hair in the 1064nm mode only.
Device Description
Medlite™ Q-Switched Nd:YAG Laser
Medlite™ IV Q-Switched Nd:YAG Laser
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K Number
K970808Device Name
MEDLITE IV Q-SWITCHED, FREQUENCY DOUBLED, ND:YAG LASER
Manufacturer
CONTINUUM BIOMEDICAL, INC.
Date Cleared
1997-09-05
(184 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CONTINUUM BIOMEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For incision, excision, ablation, vaporization of soft tissue for general dermatology, as well as at the 1064nm wavelength, dark ink (blue/black) tattoo removal and Nevus of Ota and at the 532nm wavelength, light ink (red) tattoo removal, vascular and pigmented lesions.
Device Description
Medlite IVTM consists of three main components: the power supply used to provide the proper voltage and current to the laser system, the water cooling system used to remove heat from the power supply and the optical bench consisting of the YAG rod, flashlamp, various mirrors, frequency doubler crystal and articulated arm.
The lasing action of the Medlite IVTM occurs when first the flashlamp is excited by a high voltage electrical pulse from the power supply. The excited flashlamp then emits an intense broad-spectrum light. The YAG rod absorbs most of this light and then releases the energy as laser light at 1064nm.
The Q-Switch acts as an extremely high speed shutter and can be set to release the light at pulse rates of 1, 2, 5, and 10 pulses per second or single shot. The frequency doubler can be enabled to change the 1064nm (infrared) light to a second wavelength at 532nm (green).
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K Number
K971903Device Name
SCANNING DEVICE ACCESSORY FOR USE WITH THE CB DIODE/532 ND:YAG LASER
Manufacturer
CONTINUUM BIOMEDICAL, INC.
Date Cleared
1997-08-21
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CONTINUUM BIOMEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Scanning Device Accessory for use with the CB Diode/532 TM Nd:YAG Laser for general dermatology (soft tissue ablation) and the treatment of vascular and pigmented lesions.
Device Description
The Scanning Device Accessory is a microprocessor controlled device that generates precisely defined repeatable patterns in an automated sequence to increase treatment speed and facilitate uniform ablation of tissue.
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K Number
K971879Device Name
SCANNING DEVICE ACCESSORY FOR USE WITH THE CB ERBIUM/2.94 ER:YAG LASER
Manufacturer
CONTINUUM BIOMEDICAL, INC.
Date Cleared
1997-08-14
(85 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CONTINUUM BIOMEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Scanning Device Accessory for use with the CB Erbium / 2.94TM Er:YAG Laser for general dermatology (soft tissue ablation) and skin resurfacing in the treatment of wrinkles.
Device Description
The Scanning Device Accessory is a microprocessor controlled device that generates precisely defined repeatable patterns in an automated sequence to increase treatment speed and facilitate uniform ablation of tissue.
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K Number
K970934Device Name
CB ERBIUM/2.94(TM) ER:YAG LASER
Manufacturer
CONTINUUM BIOMEDICAL, INC.
Date Cleared
1997-06-11
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CONTINUUM BIOMEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For skin resurfacing in the treatment of wrinkles
Device Description
CB Erbium / 2.94 TM Er:YAG Laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench. At 5 pulses per second an a pulse energy of 2 Joules, the average power from the laser is 10 watts.
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K Number
K963340Device Name
MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE
Manufacturer
CONTINUUM BIOMEDICAL, INC.
Date Cleared
1997-05-12
(259 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CONTINUUM BIOMEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use in dermatology for the removal of tattoos and the treatment of vascular and pigmented lesions.
Device Description
The new Dye Accessory Handpiece for the Medlite™ Nd:YAG Laser System is consists of four primary parts: the handpiece which contains a short optical cavity and focusing optics, the plastic dye module, the commercial power meter and appropriate laser safety goggles.
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K Number
K961006Device Name
MEDLITE/755 ALEXANDRITE LASER SYSTEM
Manufacturer
CONTINUUM BIOMEDICAL, INC.
Date Cleared
1996-09-11
(183 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CONTINUUM BIOMEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Treatment of pigmented lesions.
Device Description
The Medlite\755 Alexandrite Laser is a flashlamp excited Q-switched solid state laser producing a broadband wavelength of 755 ±25nm. Medlite\755™ Alexandrite Laser System is currently marketed under K935631, SE date 08/23/94, for tattoo removal.
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K Number
K961748Device Name
MEDLITE/ERBIUM LASER SYSTEM
Manufacturer
CONTINUUM BIOMEDICAL, INC.
Date Cleared
1996-07-26
(81 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CONTINUUM BIOMEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use in dermatology for the incision, excision, ablation, vaporization and hemostasis of soft tissue.
Device Description
The Medlite\Erbium Laser is an erbium laser producing laser emissions at 2.94 $\mu$ . The laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench. At 5 pulses per second and a pulse energy of 2 Joules, the average power from the laser is 10 watts.
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