Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Sandstone Medical Technologies, LLC — Predicate Candidate Screening

11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

92 daysmedian FDA review time
219 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K121162POLARIS Q-SWITCH RUBY SYSTEMSandstone Medical Technologies, LLC2012-07-18920
K110897CORTEX CO2 / ER:YAG LASER SYSTEMSandstone Medical Technologies, LLC2011-07-01930
K110502TRIPLEX ER. YAG / ND: YAG SYSTEMSandstone Medical Technologies, LLC2011-04-27640
K110304APEX ER. YAG / IPL SYSTEMSandstone Medical Technologies, LLC2011-04-08650
K100893CHEVEUX DIODE LASER SYSTEMSandstone Medical Technologies, LLC2010-06-16770
K093793LS-40 CO2 LASER SYSTEM MODEL LS-40Sandstone Medical Technologies, LLC2010-02-18700
K082407MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEMSandstone Medical Technologies, LLC2009-02-031660
K082101LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECESandstone Medical Technologies, LLC2008-11-051030
K081219APOLLO MINI IPL SYSTEMSandstone Medical Technologies, LLC2008-06-30610
K041011ULTRALIGHT II ND:YAG LASER SYSTEMSandstone Medical Technologies, LLC2004-12-142380
K040563LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WASandstone Medical Technologies, LLC2004-10-082190

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda