Lightmed Corp. FDA Record
Lightmed Corp. has 0 FDA recalls, 3 inspections, 10 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Lightmed Corp." is on file.
- Latest inspection
- Nov 14, 2019 · VAI
- Latest 510(k)
- Jun 15, 2016
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 10 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 3 | 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 FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Nov 14, 2019 | New Taipei City, Taiwan | Devices | Voluntary Action Indicated (VAI) | 3003559308 |
| Oct 15, 2015 | New Taipei City, Taiwan | Devices | No Action Indicated (NAI) | 3003559308 |
| Mar 22, 2013 | New Taipei City, Taiwan | Devices | Voluntary Action Indicated (VAI) | 3003559308 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3003559308 | New Taipei City, Taiwan | 3 | Nov 14, 2019 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K152688 | LightLas Multi-Wavelength Medical Laser System | Jun 15, 2016 |
| K142172 | LIGHTMED TRUSCAN 577 | Feb 27, 2015 |
| K124043 | LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM | Sep 26, 2013 |
| K103547 | LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM | Nov 3, 2011 |
| K091981 | LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER | Sep 28, 2009 |
| K091534 | LIGHTLAS MODEL 532 | Sep 18, 2009 |
| K090774 | LIGHTLAS SELECTOR | Aug 13, 2009 |
| K063297 | LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR | Sep 20, 2007 |
| K021538 | LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR | Aug 8, 2002 |
| K010372 | LIGHTLAS 532 PHOTOCOAGULATOR | Aug 22, 2001 |
Lightmed Corp. and the FDA: common questions
Has Lightmed Corp. received an FDA warning letter?
No FDA warning letter addressed to the name "Lightmed Corp." 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 Lightmed Corp. received an FDA Form 483?
FDA has not published a Form 483 for "Lightmed Corp." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Lightmed Corp.?
The most recent FDA inspection on file ended Nov 14, 2019 at New Taipei City, Taiwan and was classified VAI. FDA has 3 inspections of Lightmed Corp. on file.
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