Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spectragenics, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
774 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090820 | TRIA HAIR REMOVAL LASER SYSTEM | Spectragenics, Inc. | 2009-12-23 | 272 | 0 |
| K053527 | SPECTRA HAIR REMOVAL LASER | Spectragenics, Inc. | 2008-02-01 | 774 | 0 |
| K060567 | SPECTRAGENICS ATS-1 | Spectragenics, Inc. | 2006-04-28 | 56 | 0 |
| K052848 | SPECTRA HAIR REMOVAL LASER | Spectragenics, Inc. | 2005-12-27 | 81 | 0 |
| K032846 | SPECTRA PULSED DIODE LASER, MODEL DR-1 | Spectragenics, Inc. | 2003-12-11 | 91 | 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