Sandstone Medical Technologies, LLC: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Sandstone Medical Technologies, LLC” (first 2004, latest 2012), across 1 product code in 1 review panel. Median 510(k) review time under this name: 92 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 92 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 11 | 11 |
Review panels
Most recent Sandstone Medical Technologies, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121162 | POLARIS Q-SWITCH RUBY SYSTEM | GEX | 2012-07-18 | 92 |
| K110897 | CORTEX CO2 / ER:YAG LASER SYSTEM | GEX | 2011-07-01 | 93 |
| K110502 | TRIPLEX ER. YAG / ND: YAG SYSTEM | GEX | 2011-04-27 | 64 |
| K110304 | APEX ER. YAG / IPL SYSTEM | GEX | 2011-04-08 | 65 |
| K100893 | CHEVEUX DIODE LASER SYSTEM | GEX | 2010-06-16 | 77 |
| K093793 | LS-40 CO2 LASER SYSTEM MODEL LS-40 | GEX | 2010-02-18 | 70 |
| K082407 | MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM | GEX | 2009-02-03 | 166 |
| K082101 | LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE | GEX | 2008-11-05 | 103 |
| K081219 | APOLLO MINI IPL SYSTEM | GEX | 2008-06-30 | 61 |
| K041011 | ULTRALIGHT II ND:YAG LASER SYSTEM | GEX | 2004-12-14 | 238 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sandstone Medical Technologies, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Sandstone Medical (Suzhou), Inc. (3 510(k)s)
- Sandstone Diagnostics, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sandstone Medical Technologies, LLC?
FDA lists 11 510(k) clearances under the applicant name “Sandstone Medical Technologies, LLC” (first 2004, latest 2012), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sandstone Medical Technologies, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sandstone Medical Technologies, LLC is 92 days.
Which FDA product codes appear under Sandstone Medical Technologies, LLC?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 11).
Next steps
- See all 11 Sandstone Medical Technologies, LLC clearances with predicates and recalls
- Run predicate analysis for product code GEX, Sandstone Medical Technologies, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.