MELAFIND
FDA premarket approval P090012/S003 · decided 2014-10-22
Approval details
- PMA number
- P090012
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- MELAFIND
- Generic name
- Optical diagnostic device for melanoma detection
- Applicant
- Strata Skin Sciences, Inc.
- Date received
- 2014-02-12
- Decision date
- 2014-10-22
- Days to decision
- 252 days
- Decision code
- APPR
- Product code
- OYD
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Horsham, PA
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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510(k) clearances by this applicant
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| XTRAC Momentum Excimer Laser System (K193478) | Strata Skin Sciences, Inc. | 2020-01-14 |
| MMD Tip (K181480) | Strata Skin Sciences, Inc. | 2018-08-01 |