Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pharos Life Corporation — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
214 daysmedian FDA review time
286 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110735 | TANDA MAX OTC SYSTEM | Pharos Life Corporation | 2011-08-03 | 140 | 0 |
| K103415 | TANDA MAX | Pharos Life Corporation | 2011-01-03 | 42 | 0 |
| K090008 | TANDA RESTORE, MODEL PTSCS | Pharos Life Corporation | 2009-10-15 | 286 | 0 |
| K080591 | TANDA SKINCARE SYSTEM, MODEL: PTSCS | Pharos Life Corporation | 2008-11-14 | 256 | 0 |
| K070185 | TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA R | Pharos Life Corporation | 2007-08-21 | 214 | 0 |
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