MMD Tip
FDA 510(k) clearance K181480 · decided 2018-08-01
Clearance details
- K-number
- K181480
- Device name
- MMD Tip
- Applicant
- Strata Skin Sciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-06-05
- Decision date
- 2018-08-01
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Horsham, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MELAFIND (P090012/S011) | Strata Skin Sciences, Inc. | 2016-08-18 |
| MELAFIND (P090012/S010) | Strata Skin Sciences, Inc. | 2016-03-02 |
| MELAFIND (P090012/S006) | Strata Skin Sciences, Inc. | 2016-01-12 |
| MELAFIND (P090012/S004) | Strata Skin Sciences, Inc. | 2015-10-22 |
| MELAFIND (P090012/S008) | Strata Skin Sciences, Inc. | 2015-01-26 |
| MELAFIND (P090012/S005) | Strata Skin Sciences, Inc. | 2014-12-19 |
| MELAFIND (P090012/S007) | Strata Skin Sciences, Inc. | 2014-11-26 |
| MELAFIND (P090012/S003) | Strata Skin Sciences, Inc. | 2014-10-22 |