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510(k) Data Aggregation
K Number
K980753Device Name
CHROMOSCAN SCANNING SYSTEM
Manufacturer
MEHL/BIOPHILE INTL., INC.
Date Cleared
1998-06-29
(131 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MEHL/BIOPHILE INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used with the MEHL Chromos 694 Ruby Laser for the removal of unwanted body and facial hair.
Device Description
The ChromoScan is a scanner which is used with the Chromos 694 Ruby Laser for the removal of unwanted body and facial hair. The hand held ChromoScan attachment enables treatment of multiple, rather than single hairs, thereby increasing efficiency and adding to the safety of the parent laser. The unit lays down a mathematically precise treatment grid whereby overlap is reduced and thermal recovery time is optimized. It is expected to lessen potential operator error by diminishing the time and tedium associated with one-hair-at-a-time hair removal procedures. Moreover, safeguards within the Chromos 694's intrinsic software insure that the scanner's fluences do not exceed those of the basic laser, i.e., no more than 20J/cm . ChromoScan is substantially equivalent to the other laser delivery attachment, the fiber optic handpiece. Both produce the same spot size, 7mm, and energies, as shown by computergenerated thermographic profiles.
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K Number
K971814Device Name
IMPROVEMENTS TO THE MEHL RUBY LASER
Manufacturer
MEHL/BIOPHILE INTL., INC.
Date Cleared
1997-08-01
(78 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MEHL/BIOPHILE INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Chromos 694 (MEHL) Ruby Laser, Mark I, is indicated for the removal of unwanted body and facial hair.
Device Description
The Mark I Chromos 694 Ruby Laser is a laser instrument used in medical practice for the removal of unwanted body and facial hair.
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