Lightmed Corp.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Lightmed Corp.” (first 2001, latest 2016), across 1 product code in 1 review panel. Median 510(k) review time under this name: 200 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 272 |
| 2014 | 0 | — |
| 2015 | 1 | 204 |
| 2016 | 1 | 271 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HQF | Laser, Ophthalmic | 10 | 10 |
Review panels
- Ophthalmic (10)
Most recent Lightmed Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K152688 | LightLas Multi-Wavelength Medical Laser System | HQF | 2016-06-15 | 271 |
| K142172 | LIGHTMED TRUSCAN 577 | HQF | 2015-02-27 | 204 |
| K124043 | LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM | HQF | 2013-09-26 | 272 |
| K103547 | LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM | HQF | 2011-11-03 | 336 |
| K091981 | LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER | HQF | 2009-09-28 | 89 |
| K091534 | LIGHTLAS MODEL 532 | HQF | 2009-09-18 | 115 |
| K090774 | LIGHTLAS SELECTOR | HQF | 2009-08-13 | 143 |
| K063297 | LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR | HQF | 2007-09-20 | 323 |
| K021538 | LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR | HQF | 2002-08-08 | 90 |
| K010372 | LIGHTLAS 532 PHOTOCOAGULATOR | HQF | 2001-08-22 | 196 |
Recalls
openFDA lists no recalls under a recalling firm named Lightmed Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Lightmed USA, Inc. (2 510(k)s)
- Lightmed Dentaltechnology Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lightmed Corp.?
FDA lists 10 510(k) clearances under the applicant name “Lightmed Corp.” (first 2001, latest 2016), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Lightmed Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lightmed Corp. is 200 days.
Which FDA product codes appear under Lightmed Corp.?
The most frequent FDA product codes under this applicant name are HQF (Laser, Ophthalmic, 10).
Next steps
- See all 10 Lightmed Corp. clearances with predicates and recalls
- Run predicate analysis for product code HQF, Lightmed Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.