Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Light Sources, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
210 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151370 | UV Lamps for Indoor Tanning Devices | Light Sources, Inc. | 2015-12-17 | 210 | 0 |
| K901324 | U.V. SUNLAMP 95UF-II | Light Sources, Inc. | 1990-04-26 | 36 | 0 |
| K900649 | FLUORESCENT T12 UVA LAMP | Light Sources, Inc. | 1990-03-28 | 47 | 0 |
| K900693 | U.V. SUNLAMP (U.V. LIGHT, DERMATOLOGIC) | Light Sources, Inc. | 1990-03-27 | 42 | 0 |
| K883952 | U. V. SUNLAMP 95UF-11 | Light Sources, Inc. | 1988-09-28 | 9 | 0 |
| K874889 | U.V. SUNLAMP 95 UF-11 | Light Sources, Inc. | 1987-12-30 | 29 | 0 |
| K870167 | U.V. SUNLAMP 95UF-11 | Light Sources, Inc. | 1987-02-09 | 26 | 0 |
| K854004 | FLUORESCENT T12 UVA TANNING LAMP | Light Sources, Inc. | 1985-10-29 | 29 | 0 |
| K853545 | FLOURESCENT T12 UVA TANNING LAMP | Light Sources, Inc. | 1985-10-01 | 36 | 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