PMA P090012S008

Device: MELAFIND
Applicant: Strata Skin Sciences, Inc.
PMA number: P090012
Supplement: S008
Product code: OYD
Decision date: 2015-01-26
Classification: Optical Diagnostic Device For Melanoma Detection
Generic name: Optical diagnostic device for melanoma detection
Approval order statement: APPROVAL FOR CHANGES TO THE TEST PROCEDURES FOR THE HAND HELD CART ASSEMBLY; DEPLOYMENT OF NEW SOFTWARE AND INSTALLATION WORKSTATIONS AND AN UPDATE FOR THE HAND HELD TEST METHOD.

Current openFDA PMA Record#

Device: MELAFIND
Applicant: Strata Skin Sciences, Inc.
PMA number: P090012
Supplement: S008
Product code: OYD
Generic name: Optical diagnostic device for melanoma detection
Decision date: 2015-01-26
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 CHANGES TO THE TEST PROCEDURES FOR THE HAND HELD CART ASSEMBLY; DEPLOYMENT OF NEW SOFTWARE AND INSTALLATION WORKSTATIONS AND AN UPDATE FOR THE HAND HELD TEST METHOD.