Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ellman Int'L, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
107 daysmedian FDA review time
223 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102698 | PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODE | Ellman Int'L, Inc. | 2011-01-05 | 107 | 0 |
| K102368 | NON-ABLATIVE WRINKLE TREATMENT HANDPIECE | Ellman Int'L, Inc. | 2010-09-07 | 18 | 0 |
| K101967 | NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE' | Ellman Int'L, Inc. | 2010-08-12 | 30 | 0 |
| K082834 | ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IE | Ellman Int'L, Inc. | 2009-05-07 | 223 | 1 |
| K061174 | SURGI-MAX | Ellman Int'L, Inc. | 2006-06-28 | 62 | 0 |
| K042710 | SURGITRON RADIOLASE II | Ellman Int'L, Inc. | 2005-04-07 | 189 | 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