Search Results
Found 3 results
510(k) Data Aggregation
K Number
K964031Device Name
DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM
Manufacturer
Date Cleared
1996-12-23
(76 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SLT-J LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
substantially equivalent to other pulsed Nd: Y AG laser systems currently in interstate commerce for use in procedures for incision, excision, coagulation or vaporization of soft tissues, such as: subcutaneous tissues, striated and smooth muscle, mucous membranes, along with organs and glands, in both open, endoscopic and microscopic procedures.
Device Description
The DCL8 Enhanced Pulsed Nd:YAG laser system has the same operating characteristics as the pulsed Nd: Y AG laser systems offered by Sunrise Technologies and American Dental Technologies with respect to average power to tissue, pulse rates, operating controls and indicators. The DCL8 Enhanced Pulsed Nd: YAG laser system incorporates a red diode aiming beam, touch pad controls for setting of operating parameters, and uses the same input power (110 VAC) as the pulsed Nd: YAG laser systems offered by Sunrise Technologies and American Dental Technologies. The DCL8 Enhanced Pulsed Nd: YAG laser system uses the industry standard SMA 905 fiberoptic connector system for its fiberoptic delivery systems.
Ask a Question
Ask a specific question about this device
K Number
K960086Device Name
DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM
Manufacturer
Date Cleared
1996-06-03
(144 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SLT-J LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
substantially equivalent to other pulsed Nd: YAG laser systems currently in interstate commerce for use in procedures for incision, excision, coagulation or vaporization of soft tissues, such as, but not limited to: subcutaneous tissues, striated and smooth muscle, mucous membranes, along with organs and glands, in both open, endoscopic and laparoscopic procedures.
Device Description
The DCL8 Enhanced Pulsed Nd: YAG laser system incorporates a red diode aiming beam, touch pad controls for setting of operating parameters, and uses the same input power (110 VAC) as the pulsed Nd: YAG laser systems offered by Sunrise Technologies and American Dental Technologies. The DCL8 Enhanced Pulsed Nd:YAG laser system uses the industry standard SMA 905 fiberoptic connector system for its fiberoptic delivery systems. The DCL8 Enhanced Pulsed Nd: YAG laser system can be operated by either a footswitch or a fingerswitch.
Ask a Question
Ask a specific question about this device
K Number
K960905Device Name
SDL DIODE LASER SYSTEM
Manufacturer
Date Cleared
1996-06-03
(90 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SLT-J LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Not Found
Device Description
Near-infrared Diode Laser System
Ask a Question
Ask a specific question about this device
Page 1 of 1