Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Curelight, Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
119 daysmedian FDA review time
284 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041994 | MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM | Curelight, Ltd. | 2004-10-06 | 75 | 0 |
| K041569 | CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002 | Curelight, Ltd. | 2004-06-30 | 20 | 0 |
| K033183 | RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012 | Curelight, Ltd. | 2004-04-15 | 197 | 0 |
| K032383 | MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM | Curelight, Ltd. | 2003-11-28 | 119 | 0 |
| K030338 | ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002 | Curelight, Ltd. | 2003-02-12 | 12 | 0 |
| K013623 | CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420 | Curelight, Ltd. | 2002-08-16 | 284 | 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