Lumalite, Inc. FDA Record
Lumalite, Inc. has 0 FDA recalls, 0 inspections, 3 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Lumalite, Inc." is on file.
- Latest 510(k)
- Aug 30, 2002
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 3 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K021083 | VERACAM | Aug 30, 2002 |
| K002566 | LUMALITE CURE LIGHT, MODEL 2100 | Oct 19, 2000 |
| K992102 | LUMA LIGHT 2000 CURE LIGHT | Aug 31, 1999 |
Lumalite, Inc. and the FDA: common questions
Has Lumalite, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Lumalite, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Lumalite, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Lumalite, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
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