MELAFIND
FDA premarket approval P090012 · decided 2011-11-01
Approval details
- PMA number
- P090012
- Trade name
- MELAFIND
- Generic name
- Optical diagnostic device for melanoma detection
- Applicant
- Strata Skin Sciences, Inc.
- Date received
- 2009-06-03
- Decision date
- 2011-11-01
- Days to decision
- 881 days
- Decision code
- APRL
- Product code
- OYD
- Advisory committee
- General, Plastic Surgery
- Expedited review
- Yes
- Location
- Horsham, PA
- Statement
- APPROVAL FOR THE MELAFIND DEVICE. MELAFIND IS INTENDED FOR USE ON CLINICALLY ATYPICAL CUTANEOUS PIGMENTED LESIONS WITH ONE OR MORE CLINICAL OR HISTORICAL CHARACTERISTICS OF MELANOMA, EXCLUDING THOSE WITH A CLINICAL DIAGNOSIS OF MELANOMA OR LIKELY MELANOMA. MELAFIND IS DESIGNED TO BE USED WHEN A DERMATOLOGIST CHOOSES TO OBTAIN ADDITIONAL INFORMATION FOR A DECISION TO BIOPSY. MELAFIND SHOULD NOT BE USED TO CONFIRM A CLINICAL DIAGNOSIS OF MELANOMA. MELAFIND IS ONLY FOR USE BY PHYSICIANS TRAINED IN
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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 |