FDA applicant
Light-Med (Usa), Inc.
FDA records 2 decisions for Light-Med (Usa), Inc. (San Clemente, CA) from 1999 to 2019: 2 510(k) clearances. All are in product code HQF (Laser, Ophthalmic). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Light-Med (Usa), Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Light-Med (Usa), Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Light-Med”
FDA records each applicant name separately; these may or may not be the same firm.