PMA P090012S007

Device: MELAFIND
Applicant: Strata Skin Sciences, Inc.
PMA number: P090012
Supplement: S007
Product code: OYD
Decision date: 2014-11-26
Classification: Optical Diagnostic Device For Melanoma Detection
Generic name: Optical diagnostic device for melanoma detection
Approval order statement: APPROVAL FOR THE CHANGES LISTED BELOW:1) INITIAL RELEASE OF USB 2.0 FOR HAND-HELD IMAGER; 2) REDESIGNED CARD READER ASSEMBLY; 3) RELEASED ACCESSORY KIT WITH DIGITAL CAMERA; 4) HIGH CAPACITY CARD OPTION ADDED; AND 5) MODIFIED PHANTOM FIXTURE MECHANICAL TOLERANCES.

Current openFDA PMA Record#

Device: MELAFIND
Applicant: Strata Skin Sciences, Inc.
PMA number: P090012
Supplement: S007
Product code: OYD
Generic name: Optical diagnostic device for melanoma detection
Decision date: 2014-11-26
Decision code: APPR
Date received: 2014-04-29
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE CHANGES LISTED BELOW:1) INITIAL RELEASE OF USB 2.0 FOR HAND-HELD IMAGER; 2) REDESIGNED CARD READER ASSEMBLY; 3) RELEASED ACCESSORY KIT WITH DIGITAL CAMERA; 4) HIGH CAPACITY CARD OPTION ADDED; AND 5) MODIFIED PHANTOM FIXTURE MECHANICAL TOLERANCES.