Strata Skin Sciences, Inc.: FDA clearances and approvals
Strata Skin Sciences, Inc. has 2 FDA 510(k) clearances (first 2018, latest 2020), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time: 43 days. openFDA lists 1 product recall by a recalling firm named Strata Skin Sciences, Inc. It files with the SEC as STRATA Skin Sciences, Inc. (SSKN).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 57 |
| 2019 | 0 | — |
| 2020 | 1 | 29 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Strata Skin Sciences, Inc.'s cleared 510(k)s took a median 43 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 2 | 2 |
| OYD | Optical Diagnostic Device For Melanoma Detection | 1 | 0 |
Review panels
Most recent Strata Skin Sciences, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K193478 | XTRAC Momentum Excimer Laser System | GEX | 2020-01-14 | 29 |
| K181480 | MMD Tip | GEX | 2018-08-01 | 57 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P090012 | PMA | MELAFIND | 2011-11-01 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2017-01-23.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
SEC filings
STRATA Skin Sciences, Inc. (SSKN): EDGAR filings, CIK 1051514. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does Strata Skin Sciences, Inc. have?
Strata Skin Sciences, Inc. has 2 FDA 510(k) clearances (first 2018, latest 2020), plus 1 PMA decision, across 2 product codes in 1 review panel.
How long does FDA take to clear Strata Skin Sciences, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Strata Skin Sciences, Inc.'s cleared 510(k)s is 43 days.
What devices does Strata Skin Sciences, Inc. make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 2); OYD (Optical Diagnostic Device For Melanoma Detection, 1).
Has Strata Skin Sciences, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Strata Skin Sciences, Inc; the most recent began 2017-01-23. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 2 Strata Skin Sciences, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Strata Skin Sciences, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.