MELAFIND
FDA premarket approval P090012/S006 · decided 2016-01-12
Approval details
- PMA number
- P090012
- Supplement
- S006
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MELAFIND
- Generic name
- Optical diagnostic device for melanoma detection
- Applicant
- Strata Skin Sciences, Inc.
- Date received
- 2014-04-29
- Decision date
- 2016-01-12
- Days to decision
- 623 days
- Decision code
- APPR
- Product code
- OYD
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Horsham, PA
- 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.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| XTRAC Momentum Excimer Laser System (K193478) | Strata Skin Sciences, Inc. | 2020-01-14 |
| MMD Tip (K181480) | Strata Skin Sciences, Inc. | 2018-08-01 |