PMA P090012S006

Device: MELAFIND
Applicant: Strata Skin Sciences, Inc.
PMA number: P090012
Supplement: S006
Product code: OYD
Decision date: 2016-01-12
Classification: Optical Diagnostic Device For Melanoma Detection
Generic name: Optical diagnostic device for melanoma detection
Approval order statement: APPROVAL FOR THE FOLLOWING CHANGES:1) CHANGES TO THE TOLERANCES IN THE COMPUTER MOUNT AND SWITCH BRACKET;2) RELOCATION OF MOUNTING HOLES ON THE COMPLEMENTARY METAL OXIDE SEMICONDUCTOR (CMOS) PRINTED CIRCUIT BOARD (PCB); 3) OPTIMIZATION OF POWER SUPPLY CAPACITORS AND ADDITION OF RESISTOR VALUES TO TEST SET; AND; 3) CHANGES TO COMPUTER LED INDICATOR AND ASSOCIATED WIRING.

Current openFDA PMA Record#

Device: MELAFIND
Applicant: Strata Skin Sciences, Inc.
PMA number: P090012
Supplement: S006
Product code: OYD
Generic name: Optical diagnostic device for melanoma detection
Decision date: 2016-01-12
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 FOLLOWING CHANGES:1) CHANGES TO THE TOLERANCES IN THE COMPUTER MOUNT AND SWITCH BRACKET;2) RELOCATION OF MOUNTING HOLES ON THE COMPLEMENTARY METAL OXIDE SEMICONDUCTOR (CMOS) PRINTED CIRCUIT BOARD (PCB); 3) OPTIMIZATION OF POWER SUPPLY CAPACITORS AND ADDITION OF RESISTOR VALUES TO TEST SET; AND; 3) CHANGES TO COMPUTER LED INDICATOR AND ASSOCIATED WIRING.