MELAFIND
FDA premarket approval P090012/S004 · decided 2015-10-22
Approval details
- PMA number
- P090012
- Supplement
- S004
- 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
- 2015-10-22
- Days to decision
- 541 days
- Decision code
- APPR
- Product code
- OYD
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Horsham, PA
- Statement
- APPROVAL FOR A CHANGE IN THE CART HIGH POTENTIAL (HI-POT) BREAKDOWN TEST SEQUENCE AND THE RELEASE OF HAND-HELD IMAGER HI-POT BREAKDOWN TEST PROCEDURE.
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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 |