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510(k) Data Aggregation
K Number
K014035Device Name
COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS
Manufacturer
COOLTOUCH CORP.
Date Cleared
2002-03-07
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
COOLTOUCH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CoolTouch Nd:YAG Laser Systems are indicated for the treatment of periorbital and perioral wrinkles.
Device Description
The CoolTouch Nd:YAG Laser Systems are ND:YAG lasers producing laser emission at 1320 nm. The lasers consist of three interconnected sections: The cabinet, which houses the power supply, cooling system, microcontroller and the laser, the fiber optics, and the handpiece.
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K Number
K010316Device Name
COOLTOUCH VARIA ND:YAG LASER SYSTEM; COOLTOUCH VARIA-II ND:YAG LASER SYSTEM
Manufacturer
COOLTOUCH CORP.
Date Cleared
2001-05-01
(88 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
COOLTOUCH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003715Device Name
COOLTOUCH ND:YAG LASER SYSTEM, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH II
Manufacturer
COOLTOUCH CORP.
Date Cleared
2001-03-01
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
COOLTOUCH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003781Device Name
COOLTOUCH VARIA-II ND:YAG LASER SYSTEM
Manufacturer
COOLTOUCH CORP.
Date Cleared
2000-12-20
(13 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
COOLTOUCH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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