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510(k) Data Aggregation
K Number
K091323Device Name
MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200)
Manufacturer
INTERMEDIC ARFRAN, S.A.
Date Cleared
2009-06-04
(30 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
INTERMEDIC ARFRAN, S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180) is indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialties including: Urology, Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/Neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures.
Device Description
The modified INTERmedic Diode Laser 980mm System (MULTIDIODE SST 180), and the delivery accessories that are used with it, is comprised of the following main components:
- Laser console with fiber port and RF ID bracket
- Operating software
- Detachable footswitch
- Delivery device accessories (fiber optic, handpieces and scanner)
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K Number
K053540Device Name
INTERMEDIC DIODE LASER FAMILY 810NM AND 980NM (AND THE DELIVERY ACCESSORIES THAT ARE USED WITH THEM TO DELIVER LASER ENE
Manufacturer
INTERMEDIC ARFRAN, S.A.
Date Cleared
2006-09-06
(260 days)
Product Code
GEX, GEI
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
INTERMEDIC ARFRAN, S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The INTERmedic Diode Laser Family (and their delivery accessories used to deliver optical, ultrasound and RF energy) are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in coniunction with endoscopic equipment for medical specialties including: Urology, Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/Neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures.
Device Description
The INTERmedic Diode Laser Family is designed to deliver laser power at wavelengths of 810nm and 980nm, depending on model, that can be used for the procedures indicated in the section "Indication for Use" in this summary. The ContrÂge model can be used with or without the RF unit. The different models can be identified by their different names, output frequency and maximum power. Each system is comprised with the following main components: Operating software controlled by a microprocessor, A footswitch (detachable), A laser cabinet/console with fiber port, A safety Interlock.
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