Search Results
Found 1 results
510(k) Data Aggregation
K Number
K990417Device Name
DERMACOOL
Manufacturer
OPTOMED CORP.
Date Cleared
1999-04-14
(63 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
OPTOMED CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DermaCool is intended for use with a laser or light source utilized for photo-coagulation of dermatological lesions and is a cooling device indicated for:
1. The reduction of pain,
2. Less discomfort,
3. Cooling of the skin prior, during and after laser or light treatment.
Device Description
DermaCool™ is a skin-cooling device designed for lasers or light sources, which are used for skin treatment applications such as vascular lesions or hair removal. A piece of cooled sapphire window, or lens, which comes in contact with skin, performs skin cooling.
Ask a Question
Page 1 of 1