Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Esc Medical Systems , Ltd. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
169 daysmedian FDA review time
322 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K994014 | ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHT | Esc Medical Systems , Ltd. | 2000-02-24 | 90 | 0 |
| K991935 | EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEM | Esc Medical Systems , Ltd. | 2000-01-27 | 232 | 0 |
| K982119 | DIODE LASER | Esc Medical Systems , Ltd. | 1999-02-04 | 233 | 0 |
| K974536 | PHOTODERM HR SYSTEM | Esc Medical Systems , Ltd. | 1998-05-20 | 169 | 0 |
| K980537 | ND: YAG ACCESSORY FOR PHOTODERM SYSTEM | Esc Medical Systems , Ltd. | 1998-04-15 | 63 | 0 |
| K972872 | DERMA K LASER SYSTEM | Esc Medical Systems , Ltd. | 1997-10-28 | 85 | 0 |
| K972028 | DERMASCAN SURGICAL LASER SCANNER | Esc Medical Systems , Ltd. | 1997-10-24 | 144 | 0 |
| K963249 | EPILIGHT HAIR REMOVAL SYSTEM | Esc Medical Systems , Ltd. | 1997-07-07 | 322 | 0 |
| K964253 | DERMA 20 LASER SYSTEM | Esc Medical Systems , Ltd. | 1997-04-11 | 169 | 0 |
| K960772 | PHOTODERM PL. | Esc Medical Systems , Ltd. | 1996-09-11 | 198 | 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